Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial

Background There are over 2 million newly diagnosed patients with breast cancer worldwide with more than 10,000 cases in Taiwan each year. During 2017-2018, the National Yang-Ming University, the Taiwan University of Science and Technology, and the Taiwan Breast Cancer Prevention Foundation collaborated to develop a breast cancer self-management support (BCSMS) mHealth app for Taiwanese women with breast cancer. Objective The aim of this study was to investigate the quality of life (QoL) of women with breast cancer in Taiwan after using the BCSMS app. Methods After receiving a first diagnosis of breast cancer, women with stage 0 to III breast cancer, who were recruited from social networking sites or referred by their oncologists or oncology case managers, were randomized 1:1 into intervention and control groups. Intervention group subjects used the BCSMS app and the control group subjects received usual care. Two questionnaires—the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and the EORTC Breast Cancer-Specific Quality-of-Life Questionnaire (QLQ-BR23)—were distributed to subjects in both arms. Paper-based questionnaires were used at baseline; paper-based or Web-based questionnaires were used at 1.5-month and 3-month follow-up evaluations. All evaluations were self-assessed and anonymous, and participants were blinded to their allocation groups. Descriptive analysis, the Pearson chi-square test, analysis of variance, and the generalized estimating equation were used to analyze the data. Missing values, with and without multi-imputation techniques, were used for sensitivity analysis. Results A total of 112 women were enrolled and randomly allocated to either the experimental group (n=53) or control group (n=59). The follow-up completion rate was 89.3% (100/112). The demographic data showed homogeneity between the two groups in age (range 50-64 years), breast cancer stage (stage II), marital status (married), working status (employed), and treatment status (receiving treatments). The mean total QoL summary scores from the QLQ-C30 (83.45 vs 82.23, P=.03) and the QLQ-BR23 (65.53 vs 63.13, P=.04) were significantly higher among the experimental group versus the control group, respectively, at 3 months. Conclusions This research provides support for using a mobile health care app to promote the QoL among women in Taiwan after a first diagnosis of breast cancer. The BCSMS app could be used to support disease self-management, and further evaluation of whether QoL is sustained is warranted. Trial Registration ClinicalTrials.gov NCT004174248; https://clinicaltrials.gov/ct2/show/NCT04174248

yes: all primary outcomes were signiPcantly better in intervention group vs control partly: SOME primary outcomes were signiPcantly better in intervention group vs control no statistically signiPcant difference between control and intervention potentially harmful: control was signiPcantly better than intervention in one or more outcomes inconclusive: more research is needed Overall, was the app/intervention e$ective? * TITLE AND ABSTRACT 1a) TITLE: Identi!cation as a randomized trial in the title yes Is this a full powered e$ectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) ms#17084 1a) Does your paper address CONSORT item 1a? * Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if orine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The Quality of Life for Women after First Diagnosis of Breast Cancer Using a Self-Management Support "mHealth Application" in Taiwan: A Randomized Control Trial

1a-ii) Non-web-based components or impo"ant co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study We do not include a co-intervention in this work.

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The Quality of Life for "Women after First Diagnosis of Breast Cancer" Using a Self-Management Support "mHealth Application" in Taiwan Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "After receiving their Prst diagnosis of breast cancer, women with stage 0 to III from a social networking sites/referred by their oncologists and oncology case manager were randomized 1:1 into intervention and control groups. Intervention group subjects used BCSMS App and the control group subjects received usual care."

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. orine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional orine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Two questionnaires: EORTC QLQ-C30 and EORTC QLQ-BR 23 were distributed to subjects in both arms at baseline "with paper-based form" and at 1.5 and 3 months "with web-based form". All evaluations were "self-assessed with anonymous and blinded." 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "A total of 112 women were enrolled and randomly allocated to the experimental (n=53) or the control (n=59)  Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Mobile applications are also developed for breast cancer self-management [24][25][26][27]. However, we are unaware of mobile self-management apps developed speciPcally for Taiwanese women with breast cancer. Therefore, our team developed the breast cancer selfmanagement support mHealth app (called as BCSMS App) to address this gap. The development and usability testing of the BCSMS App has been reported previously [28]. Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The use of mobile applications (Apps) by patients with cancer is becoming more common. More than half of patients with cancer are willing to transmit information through an App to support their treatment and 84% of medical professionals (mainly physicians) support the use of apps with this population [22,23]. One study suggests that the Apps can support outpatient visits, documentation of adverse events, treatment and medication reminders [22].
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The purpose of this study was to evaluate the impact of using the BCSMS App on the QoL of Taiwanese women after an initial diagnosis of breast cancer." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Impo"ant changes to methods a#er trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The study was "a single blinded, parallel group randomized controlled trial" with pre-test (T0), post-one and a half month (T1), and post-three-month (T2) follow-up evaluations. "Each eligible participant was randomly assigned 1:1 into one of two study groups (control or experimental). The randomization scheme was generated by using the Web site Randomization.com ⟨http://www.randomization.com⟩ [33]." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No important changes to methods after trial commencement Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study There were no bug Pxes, downtimes, or content changes needed in this trial.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Women with breast cancer who met the following inclusion criteria were recruited: "(1) Prst diagnosis of breast cancer with stage 0 to III in past year; (2) aged 20 to 65 years; (3) had an Android/iOS smartphone; (4) able to read and write in Chinese; (5) willing to participate in the study and provide informed consent." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariPed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. orine), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conPrmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Data collection was from January to July in 2019 by the study team. Patients were blinded whether they were in the experimental or control group and their pre-test data were collected via a paper-based instrument. After the pre-test data was collected, the BCSMS App was installed on the experimental participants' smart phones and they were taught how to use it. Each experimental participant could use BCSMS App in any time as needed (e.g. no any prompts/reminders from the study team). The entire pre-test study design was done with face to face contact. The two post follow-up evaluation data collections were completed via a web-based instrument with phone call, email and communication software (e.g. Line) contacting. Paper-based instruments were provided for participants that choose not to use the web-based instruments. All evaluations were anonymous. After the study, every participant was provided 3 USD for each pre-test and post follow-up evaluation. During data collection, the content of BCSMS App was frozen during the trial and only supported the intervention group with overcoming any technical problems associated with the BCSMS App (e.g. login problems, data entry problems etc.).

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "To blind the study group participants to allocation [31] and prevent the selection bias (e.g. technology novelty bias) [32], the recruitment ad only recruited participants for a QoL evaluation after cancer treatment only (no mention of the BCSMS app). The recruitment poster was used by recruiters to introduce the patients to the purpose of study. … The eligible participants were provided two different informed consents according to their assigned groups. The consents included the same information on the protocol of their quality of life data collection and every participant was provided 3 USD for each pre-test and post follow-up evaluation after the study. The difference information on the experiment groups' consents were 1). briePng the contents of the BCSMS App; 2) BCSMS App would be installed in their smartphone with technology support remotely" Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The study sites were in the outpatient clinics in two medical centers and one area hospital in northern Taiwan." … "The entire pre-test study design was done with face to face contact in the study sites. The two post follow-up evaluation data collections were completed via a web-based instrument with phone call, email and communication software (e.g. Line) contacting. Paper-based instruments were provided for participants that choose not to use the web-based instruments." Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The two post follow-up evaluation data collections were completed via a web-based instrument with phone call, email and communication software (e.g. Line) contacting."

4b-ii) Repo" how institutional a!liations are displayed
Report how institutional azliations are displayed to potential participants [on ehealth media], as azliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with su%cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The study sites were in the outpatient clinics "in two medical centers and one area hospital in northern Taiwan". … "Participants were recruited in two different ways. First, a recruitment ad was posted on the Taiwan Cancer Foundation (TBCF) social networking sites (e.g. Facebook, Line) and interested participants contacted us through the online registration. Second, patients were referred by their oncologists and oncology case manager from the study setting."

5-i) Mention names, credential, a!liations of the developers, sponsors, and owners
Mention names, credential, azliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Consict of interest" section or mentioned elsewhere in the manuscript). Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "In Taiwan, since June 2017, National Yang-Ming University, Taiwan University of Science and Technology, and Taiwan Breast Cancer Prevention and Research Foundation collaborated to develop a BCSMS App."

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "In Taiwan, since June 2017, National Yang-Ming University, Taiwan University of Science and Technology, and Taiwan Breast Cancer Prevention and Research Foundation collaborated to develop a BCSMS App. A total of eight main features included 1) the evidence or "knowledge" about breast cancer disease, 2) "exercise and rehabilitation" after surgery, 3) "diet and nutrition" for breast cancer patients, 4) "emotional support" to prevent anxiety and depression, 5) "personal health record" for tracking treatment and side effects, 6) "social resource" information, 7) "experience sharing", and 8) "expert consulting". When pilot testing the BCSMS App with 45 Taiwanese women with breast cancer in 2018 using the modiPed technology acceptance model of mobile services (TAMM) survey, our team found that the BCSMS App had sound usability and was accepted by the participants."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "During data collection, the content of BCSMS App was frozen during the trial and only supported the intervention group with overcoming any technical problems associated with the BCSMS App (e.g. login problems, data entry problems etc.)."

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable. Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "When pilot testing the BCSMS App with 45 Taiwanese women with breast cancer in 2018 using the modiPed technology acceptance model of mobile services (TAMM) survey, our team found that the BCSMS App had sound usability and was accepted by the participants." 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing &owcha"s of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing sowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiPc reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Now the BCSMS App is outsourced to a technology company for long term maintenance and can be downloaded for widespread use. "(To access, search keywords "ibreast" for iOS version and "pink passport( in Chinese)" for Android version."

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciPc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi). Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Today, the "self-management" model is generally valued and promoted in Taiwan and abroad [13][14][15]. Self-management is different from traditional disease management which includes education, emphasizing patient-centered, disease-oriented self-management and taking the initiative to participate in health care activities. With self-management, the patient learns problem solving, disease control, life adjustment, physical and mental symptom management and lifestyle changes, in order to coexist with a chronic disease in daily life." "In Taiwan, since June 2017, National Yang-Ming University, Taiwan University of Science and Technology, and Taiwan Breast Cancer Prevention and Research Foundation collaborated to develop a BCSMS App. A total of eight main features included 1) the evidence or "knowledge" about breast cancer disease, 2) "exercise and rehabilitation" after surgery, 3) "diet and nutrition" for breast cancer patients, 4) "emotional support" to prevent anxiety and depression, 5) "personal health record" for tracking treatment and side effects, 6) "social resource" information, 7) "experience sharing", and 8) "expert consulting"."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum. Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study the BCSMS App was installed on the experimental participants' smart phones and they were taught how to use it. "Each experimental participant could use BCSMS App in any time" and no any prompts/reminders from the study team.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study During data collection, the content of BCSMS App was frozen during the trial and "the evaluator (HY) supported the intervention group with overcoming any technical problems associated with the BCSMS App (e.g. login problems, data entry problems etc.)." Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Each experimental participant could use BCSMS App in any time as needed (e.g. no any prompts/reminders from the study team)."

5-xii) Describe any co-interventions (incl. training/suppo")
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. 2019/11/28 下午6)22 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form ⾴頁⾯面 31/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 6a) Completely de!ned pre-speci!ed primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No co-interventions were used.
Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The QoL instrument consisted of two parts. The Prst part included demographics items (e.g. age, disease stage, marital status, working status etc.) and treatment-related items. The second part was the Taiwan Chinese version of the EORTC QLQ-C30 (version 3) and EORTC QLQ-BR23 which were originally developed by European Organization for Research and Treatment of Cancer (EORTC) [34,35]. These instruments have good test/retest reliability, high internal consistency in most scales, and show expected differences between patients in active chemotherapy and follow-up groups [36]. The QLQ-C30 incorporates Pve functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); nine symptom scales (fatigue, nausea and vomiting pain, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and Pnancial dizculties); and global health status and quality-of-life (QoL) scales [34]. The EORTC QLQ-BR23 is the module for breast cancer. It incorporates four functional scales (body image, sexual functioning, sexual enjoyment, and future perspective); and four symptom scales (systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss) [37]. According to the EORTC scoring manual, a high score for a functional scale represents a high / healthy level of functioning at QLQ C-30 and QLQ-BR23, a high score for the global health status / QoL represents a high QoL at QLQ C-30, but a high score for a symptom scale / item represents a high level of symptomatology / problems at QLQ C-30 and QLQ-BR23 [38]." 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de%ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was dePned/measured/monitored (logins, logPle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No any changes to trial outcomes after the trial commenced subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected a'rition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Apriori power analysis was calculated using G*Power version 3.1 with: F tests, ANOVA: Repeated measures, between factors, medium effect size= 0.25, signiPcant level = 0.05, power = 0.8 was used for sample size calculation according to Cohen [30]. "The apriori sample size was 41 in each group. We oversampled our eligible patient population to account for potential drop-outs and expected to include a total of 106 patients in this study." 2019/11/28 下午6)22 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form ⾴頁⾯面 35/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Each eligible participant was randomly assigned 1:1 into one of two study groups (control or experimental). To balance the number of participants' severity of disease in each group, breast cancer with stage 0 to III as four blocks were used. The number of subjects per block were according to their incidence rate in Taiwan (e.g. stage 0=17%, stage I=31%, stage II=32%, stage III=13%, and stage IV=7%,) [1].Considering the patients with breast cancer stage IV would not be matched to our inclusion criteria. The percentage of stage IV(7%) was divided according to the proportion of stage 0 to stage III and then the proposed sample percentage of stage 0 was 18.3%, stage I was 33.3%, stage II was 34.4%, stage III=14%. Then the proposed sample size of each block would be 20 for stage 0(e.g.106*18.3%=19.4 carry), 36 for stage I, 36 for stage II, and 14 for stage III consequently. The randomization scheme was generated by using the Web site Randomization.com ⟨http://www.randomization.com⟩ [33]." 2019/11/28 下午6)22 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form ⾴頁⾯面 36/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Each eligible participant was randomly assigned 1:1 into one of two study groups (control or experimental). To balance the number of participants' severity of disease in each group, breast cancer with stage 0 to III as four blocks were used. The number of subjects per block were according to their incidence rate in Taiwan (e.g. stage 0=17%, stage I=31%, stage II=32%, stage III=13%, and stage IV=7%,) [1].Considering the patients with breast cancer stage IV would not be matched to our inclusion criteria. The percentage of stage IV(7%) was divided according to the proportion of stage 0 to stage III and then the proposed sample percentage of stage 0 was 18.3%, stage I was 33.3%, stage II was 34.4%, stage III=14%. Then the proposed sample size of each block would be 20 for stage 0(e.g.106*18.3%=19.4 carry), 36 for stage I, 36 for stage II, and 14 for stage III consequently. The randomization scheme was generated by using the Web site Randomization.com ⟨http://www.randomization.com⟩ [33]." 2019/11/28 下午6)22 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form ⾴頁⾯面 37/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Each eligible participant was randomly assigned 1:1 into one of two study groups (control or experimental). To balance the number of participants' severity of disease in each group, breast cancer with stage 0 to III as four blocks were used. The number of subjects per block were according to their incidence rate in Taiwan (e.g. stage 0=17%, stage I=31%, stage II=32%, stage III=13%, and stage IV=7%,) [1].Considering the patients with breast cancer stage IV would not be matched to our inclusion criteria. The percentage of stage IV(7%) was divided according to the proportion of stage 0 to stage III and then the proposed sample percentage of stage 0 was 18.3%, stage I was 33.3%, stage II was 34.4%, stage III=14%. Then the proposed sample size of each block would be 20 for stage 0(e.g.106*18.3%=19.4 carry), 36 for stage I, 36 for stage II, and 14 for stage III consequently. The randomization scheme was generated by using the Web site Randomization.com ⟨http://www.randomization.com⟩ [33]." 2019/11/28 下午6)22 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form ⾴頁⾯面 38/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 10) Who generated the random allocation sequence, who enrolled pa"icipants, and who assigned pa"icipants to interventions 11a) If done, who was blinded a#er assignment to interventions (for example, pa"icipants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Each eligible participant was randomly assigned 1:1 into one of two study groups (control or experimental) by the evaluator (HY). "Each eligible participant was randomly assigned 1:1 into one of two study groups (control or experimental). To balance the number of participants' severity of disease in each group, breast cancer with stage 0 to III as four blocks were used. The number of subjects per block were according to their incidence rate in Taiwan (e.g. stage 0=17%, stage I=31%, stage II=32%, stage III=13%, and stage IV=7%,) [1].Considering the patients with breast cancer stage IV would not be matched to our inclusion criteria. The percentage of stage IV(7%) was divided according to the proportion of stage 0 to stage III and then the proposed sample percentage of stage 0 was 18.3%, stage I was 33.3%, stage II was 34.4%, stage III=14%. Then the proposed sample size of each block would be 20 for stage 0(e.g.106*18.3%=19.4 carry), 36 for stage I, 36 for stage II, and 14 for stage III consequently. The randomization scheme was generated by using the Web site Randomization.com ⟨http://www.randomization.com⟩ [33]." Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Each eligible participant was randomly assigned 1:1 into one of two study groups (control or experimental) by the evaluator (HY) " 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Patients were blinded whether they were in the experimental or control group and their pretest data were collected via a paper-based instrument." 11a-ii) Discuss e.g., whether pa"icipants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study To blind the study group participants to allocation [31] and prevent the selection bias (e.g. technology novelty bias) [32], the recruitment ad only recruited participants for a QoL evaluation after cancer treatment only (no mention of the BCSMS app). "The recruitment poster was used by recruiters to introduce the patients to the purpose of study." Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Frequency, percentage, mean, standard deviation was used for descriptive statistic for clinical variables, QLQ-C30 and QLQ-BR23. We compared the baseline of the control and the experimental groups using chi-square tests for categorical variables and t-test for continuous variables. All analyses were intent-to-treat using a repeated measures analysis- GEE [41]. This method was used to account for the lack of adherence values over time and to detect any time × group effects among the target indicators. SigniPcance was dePned as p value <0.05."

12a-i) Imputation techniques to deal with a'rition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "For data missing at random value (MARV), multi-imputation technique was used [38,40] and average score of the observed data at the same follow-up interval in the same group was adopted to impute the MARV." Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The eligible participants were provided two different informed consents according to their assigned groups. The consents included the same information on the protocol of their quality of life data collection and every participant was provided 3 USD for each pre-test and post follow-up evaluation after the study. The difference information on the experiment groups' consents were 1). briePng the contents of the BCSMS App; 2) BCSMS App would be installed in their smartphone with technology support remotely"

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) ⾴頁⾯面 44/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 RESULTS 13a) For each group, the numbers of pa"icipants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions a#er randomisation, together with reasons Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The protocol was determined to be of minimal risk to the participants. Nevertheless, all participant data was anonymized and stored on an encrypted, password protected server.
Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Randomization and attrition data were organized according to CONSORT guideline [42] (Figure 1)". A total of 112 eligible women after initial diagnosis of non-metastatic breast cancer were enrolled and randomly allocated to the experimental (n = 53) or the control (n = 59) group. Reasons for patient dropout included feeling sick during treatment (n = 6) lost to follow up (n=3) and concern for their personal privacy (n=3). A total of 48 participants remained in the experimental group and 52 in the control group at the three-month follow up.
⾴頁⾯面 45/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 subitem not at all important 1 2 3 4 5 essential 14a) Dates de!ning the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT &ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Randomization and attrition data were organized according to CONSORT guideline [42] (Figure 1). A total of 112 eligible women after initial diagnosis of non-metastatic breast cancer were enrolled and randomly allocated to the experimental (n = 53) or the control (n = 59) group. "Reasons for patient dropout included feeling sick during treatment (n = 6) lost to follow up (n=3) and concern for their personal privacy (n=3)." A total of 48 participants remained in the experimental group and 52 in the control group at the three-month follow up.

13b-i) A'rition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Pgures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Pgure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Randomization and attrition data were organized according to CONSORT guideline [42] " (Figure 1)".
subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Data collection was from January to July in 2019 by the study team." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiPcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study None Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not Applicable -The trial did not end early. Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The demographics and baseline QoL from the two groups were similar. The largest age group was 50-64 (45.5%). Participants had bachelor's degree or equivalent education (30.4%). Over half (69.6%) of the participants were married. One-third of them had two children (38.4%). Close to half (46.4%) of the participants were employed. The majority of participants did not have any comorbid diagnoses (87.5%). The largest number had breast cancer stage II (39.5%), received breast conservation surgery (65.2%), chemotherapy (65.2%), radiotherapy (59.3%) and hormone therapy (53.6%). There were no statistical differences between control and experimental participants with regard to any of the baseline characteristics. "Detailed statistical results are shown in Table 2."

15-i) Repo" demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
16) For each group, number of pa"icipants (denominator) included in each analysis and whether the analysis was by original assigned groups subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The largest age group was 50-64 (45.5%). Participants had bachelor's degree or equivalent education (30.4%). Over half (69.6%) of the participants were married. One-third of them had two children (38.4%). Close to half (46.4%) of the participants were employed. …Detailed statistical results are shown in Table 2."

16-i) Repo" multiple "denominators" and provide de%nitions
Report multiple "denominators" and provide dePnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciPc pre-dePned time points of interest (in absolute and relative numbers per group). Always clearly dePne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Detailed statistical results are shown in Table 2." 17a) For each primary and secondary outcome, results for each group, and the estimated e&ect size and its precision (such as 95% con!dence interval)

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "After 1.5-month and 3-months post-follow up evaluation, these scores were 79.13 (SD 15.31) and 83.45 (SD = 10.85) in experimental group, and 79.49 (SD = 12.41) and 82.23 (SD = 12.07) in control group. The total summary scores for QLQ-C30 in both groups showed a signiPcant improvement by 3-months (difference between T2 to T0 is 8.98 in experimental group and is 3.93 in control group). GEE analysis showed statistical difference (p = 0.03) in the interactions between groups and time meaning the experimental group had greater total summary scores for QLQ-C30(diff=5.05) than the control group after intervention at the 3month assessment interval (Table 3)." Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Mean, standard deviation, difference, p-value are given for each outcome in the manuscript. subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative e&ect sizes is recommended 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational dePnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is dePned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study After 1.5-month and 3-months post-follow up evaluation, these scores were 79.13 (SD 15.31) and 83.45 (SD = 10.85) in experimental group, and 79.49 (SD = 12.41) and 82.23 (SD = 12.07) in control group. The total summary scores for QLQ-C30 in both groups showed a signiPcant improvement by 3-months (difference between T2 to T0 is 8.98 in experimental group and is 3.93 in control group). GEE analysis showed statistical difference (p = 0.03) in the interactions between groups and time meaning the experimental group had greater total summary scores for QLQ-C30(diff=5.05) than the control group after intervention at the 3month assessment interval (Table 3).
18) Results of any other analyses pe'ormed, including subgroup analyses and adjusted analyses, distinguishing pre-speci!ed from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

Not applicable
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii). Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 22-i) Restate study questions and summarize the answers suggested by the data, sta"ing with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? *

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
⾴頁⾯面 56/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 21) Generalisability (external validity, applicability) of the trial !ndings NPT: External validity of the trial Pndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "There were two main limitations of this study. The Prst was maturation bias as our study followed participants for only three months. Although the control group did not use the BCSMS App, they still had supportive care from professionals (e.g. physicians, oncology case managers etc.) and perhaps their information searching competence helped them with self-management and increase their QoL. The second was that we did not know the actual frequency of use of the BCSMS App in the experimental group. To prevent the Hawthorne Effect (e.g. causing non routine practices) [50] the research team did not remind the subjects in the experimental group to use BCSMS App . Such limitations might have insuenced the results in this study."
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The purpose of the study was to investigate the QoL for women with breast cancer in Taiwan after using the BCSMS App. According to the results, women with Prst diagnosis breast cancer have evidence of getting better QoL after receiving cancer treatment. When providing the BCSMS App to them, it provides conservative evidence to promote the QoL than those did not use. It might because the BCSMS App deliver the comprehensive information (e.g. eight main features in prior work) to the women with breast cancer when they Prst encounter the dizculty in their life and satisPed their needs during the treatment. The next steps would introduce the BCSMS App to more breast cancer patients and the further evaluation of whether QoL is sustained 21-ii) Discuss if there were elements in the RCT that would be di$erent in a routine application se'ing Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 2019/11/28 下午6)22 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form ⾴頁⾯面 58/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 OTHER INFORMATION 23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other suppo" (such as supply of drugs), role of funders Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "This study followed the ethical principles of the Declaration of Helsinki [29] and approved by the Institute of Review Board in National Yang Ming University (IRB No. YM107109E) in Taiwan." We also wait for the ClinicalTrials.gov ID and currently the ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt was downloaded Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "This study followed the ethical principles of the Declaration of Helsinki [29] and approved by the Institute of Review Board in National Yang Ming University (IRB No. YM107109E) in Taiwan." We currently wait for the ClinicalTrials.gov ID and the ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt was provided as appendix.
⾴頁⾯面 59/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 X27) Con(icts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study We appreciate the funding form Ministry of Science and Technology (MOST107 -2314 -B -010 -052) and all team members in this research and Taiwan Breast Cancer Foundation. Special thanks to Jhou-Liang Lian, Kong-Hao Chen, Zih-Bin Chen for their support.

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (Pnancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study None declared.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

hours
As a result of using this checklist, do you think your manuscript has improved? * 2019/11/28 下午6)22 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form ⾴頁⾯面 61/61 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 yes no STOP -Save this form as PDF before you click submit To generate a record that you Plled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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