Long-Term Effectiveness of a Decision Support App (Pink Journey) for Women Considering Breast Reconstruction Surgery: Pilot Randomized Controlled Trial

Background Various kinds of breast reconstruction (BR) options, including implants and autologous, and surgery techniques, including traditional and endoscope assisted, can be used to perform surgery. All options have their own advantages and disadvantages. Women decide on an option depending on the values and preferences they emphasize. Lacking knowledge about BR or having decision difficulties during the treatment decision process makes women experience more decision regret, psychological distress, and poor body image. Delivering decision support with a values clarification exercise using eHealth approaches would be beneficial for patient outcomes. Objective This study aims to examine the effects of a decision support app on decision-making quality and psychological morbidity for women considering BR surgery. Methods This randomized controlled trial included women who were over 20 years of age and were newly diagnosed with breast cancer and candidates for mastectomy. Women having an option for breast conservation were excluded. After being referred from the outpatient physician, the women provided consent and completed the baseline assessment. Women allocated to the control group (CG) received usual care and were provided with a pamphlet with information about types of surgery and the advantages and disadvantages of different surgery types. Women allocated to the intervention group (IG) were given the same pamphlet and guided to use the Pink Journey app to support their decision. Then they were also prompted to discuss the opinions with their significant others. Finally, the decision-making process of using the app was printed out for women that they could take home. Decision conflict, anxiety, and depression were measured at baseline. At 1 week after the intervention (T1) and at 1 month (T2), 8 months (T3), and 12 months (T4) after surgery, the women completed decision conflict, decision regret, anxiety, depression, and body image scales. An intention-to-treat analysis was performed. Results From February 2018 to July 2019, 96 women were randomly assigned to the CG (n=48) or the IG (n=48). Results revealed that body image distress declined significantly for the IG but increased for the CG. The interaction of time and group also reached significance, indicating a significant decrease in body image distress from baseline in the IG compared with the CG after the 12th month (T4) follow-up (β=–2.25, standard error=1.01, P=.027). However, there was no significant difference in decision conflict (P=.21-.87), decision regret (P=.44-.55), anxiety (P=.26-.33), and depression (P=.20-.75), indicating that the decrease in these outcomes in the IG was not greater than those in the CG. Conclusions Although we found no effect on decision conflict, decision regret, anxiety, and depression, a decision aid that combines surgery information and values clarification can help women reduce their body image distress. Trial Registration ClinicalTrials.gov NCT04190992; https://clinicaltrials.gov/ct2/show/NCT04190992

Approx. Percentage of Users (sta"ers) still using the app as recommended a#er 3 months * 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 not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet published Overall, was the app/intervention e$ective? * A"icle Preparation Status/Stage * At which stage in your article preparation are you currently (at the time you Pll in this form) Is this a full powered e$ectiveness trial or a pilot/feasibility trial? * TITLE AND ABSTRACT 1a) TITLE: Identi!cation as a randomized trial in the title yes 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-31092 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 yes, Long-term Effectiveness of the Decision Support App for Women Considering Breast Reconstruction Surgery: A Pilot Randomized Controlled 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"). 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 no, because the control group received the usual care.

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 yes, Long-term Effectiveness of the Decision Support App for Women Considering Breast Reconstruction Surgery: A Pilot Randomized Controlled Trial  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 "Women allocated to the control group (CG) received usual care and were provided with a pamphlet with information about types of surgery and the advantages and disadvantages of different surgery types. Women allocated to the intervention group (IG) were given the same pamphlet and guided to use the Pink Journey app to support their decision." 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). 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 No, because the limited words to describe this information.
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 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 No, because this information was provided in the feasibility of our study in other paper. 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 "Decision connict, anxiety and depression were measured at baseline. At one week after intervention (T1) and at one month (T2), eight months (T3), and 12 months (T4) after surgery, the women completed decision connict, decision regret, anxiety, depression, and body image scales. "

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. 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 "Although we found no effect on decision connict, decision regret, anxiety, and depression, decision aid that combines surgery information and values clariPcation can help women reduce their body image distress."

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 " The effect of decision support on other psychological indicators such as anxiety, depression, and body image was rare and needs to be further explored " 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 ". ....downloaded applications (apps) are more convenient than other devices with or without an Internet connection" 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 aim of this study is to examine the effects of a decision support app on decision related outcomes and ......" 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 " 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 Because we do not have "unexpected events, so there is no change to describe.
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 were eligible for participation if they were (1) 20 years of age or older, (2

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 Not concern, since nurse instruct patients to use the app 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 We only use face to face assessment. "hey were coached on how to use a values calciPcation exercise that elicited them to ....."

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.
Does your paper address subitem 4a-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 " Consenting women were randomized using online automated randomization software to determine group ....." 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 " This study was approved by the Institution Review Board approval of National Cheng Kung University Hospital.......

4b-i) Repo" if outcomes were (self-)assessed through online questionnaires
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 following Pve instruments using a paper format were also administered at T0-T4....." 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 No mention this information, since most cancer patients received treatment in medical center in our country.

5-i) Mention names, credential, a!liations of the developers, sponsors, and owners
Mention names, credential, axliations 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 we do not have connict of interest

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 "the decision-making process of using the app was printed out for women to bring home Detailed information of the Pink Journey app was published"

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 " the decision-making process of using the app was printed out for women to bring home Detailed information of the Pink Journey app was published"

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 ".the decision-making process of using the app was printed out for women to bring home Detailed information of the Pink Journey app was published" 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 We provide Pgure 1 to show the screen-capture video

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 No, we did not put the app in the public

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). CONSORT-EHEALTH V 1.

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 We only provide one time use

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 We provide the information in the feasibility study.

5-xi) Repo" any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
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 We do not provide the prompts. subitem not at all important 1 2 3 4 5 essential 6a) Completely de!ned pre-speci!ed primary and secondary outcome measures, including how and when they were assessed 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. 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 "Women allocated to the control group (CG) received usual care from health care providers. They were also provided with a pamphlet with information ......." 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 yes, "At one week after intervention (T1) and at one month (T2), eight months (T3), and 12 months (T4) after surgery, the women completed a follow-up questionnaire during their routine clinic visits. ..." We only provide intervention one time.
6a-iii) Describe whether, how, and when qualitative feedback from pa"icipants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text We provided this information in the feasibility study that have been published.
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, we do not change to trial outcomes.

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 We put it in limitation since relevant small sample in our trial 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 No, our trail did not have negative outcomes 2021/10/19 11'29 CONSORT-EHEALTH V 1.6.1 -Submission/Publication Form 34/57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 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 ". Consenting women were randomized using online automated randomization software to determine group " 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 ". This 1:1 randomized controlled parallel-arm trial with permuted block randomization that compares...." 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 "An independent research assistant generated the allocation sequence and prepared 136 numbered, opaque, sealed envelopes with assignments to be equally distributed between the two study groups. " 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 " An independent research assistant generated the allocation sequence and prepared 136 numbered, opaque, sealed envelopes with assignments to be equally distributed between the two study groups. 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 " The participants were not blinded to their allocation. " 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".
37/57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 " The participants were not blinded to their allocation. " 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 " Women allocated to the intervention group (IG) were given the same pamphlet and were further guided to use Pink Journey app to support their decision" 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 " An intention-to-treat analysis was conducted using a mixed-effects model analysis using SPSS (V. 24) with signiPcance at p < .05. A mixed-effects model that included the study group, a categorical indicator of time, and....." 38/57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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 "Missing data was not imputed due to low attrition rate (17%), but restricted maximum likelihood estimation was used for data management." Does your paper address CONSORT subitem 12b? * 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 "An intention-to-treat analysis was conducted using a mixed-effects model analysis using SPSS (V. 24) with signiPcance at p < .05. A mixed-effects model that included the study group, a categorical indicator of time, and the interaction between groups and times was generated after controlling covariates....." 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 was approved by the Institution Review Board approval of National Cheng Kung University (B-ER-106-072) and was in accordance with the ethical principles of the Declaration of Helsinki.

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained orine or online (

RESULTS
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 "fter informed consent was signed, they completed the baseline assessment. "

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) 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 "" This study was approved by the Institution Review Board approval of National Cheng Kung University (B-ER-106-072) and was in accordance with the ethical principles of the Declaration of Helsinki. " 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 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 " A total of 104 women were referred by the physician and completed the baseline questionnaires. Eight subjects dropped out ........" 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 ".....they were rejected for surgery (n = 1), scheduled for delayed (n = 1), prophylactic (n = 2), oncoplastic BR (n = 3), or had a psychiatric disease (n = 1) (Figure 2)." 42/57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 14a) Dates de!ning the periods of recruitment and 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 We provide Figure 2 to show the information.
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 " They were enrolled from February 2018 to July 2019 and completed their last follow-up in February 2021." 43/57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualiPcation, expertise, etc.) and centers (volume) in each group 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 We do not change the software.
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 We do not stop our study earlier. subitem not at all important 1 2 3 4 5 essential 16) For each group, number of pa"icipants (denominator) included in each analysis and whether the analysis was by original assigned groups 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 " At baseline, there were no between-group differences in terms of demographic (Table 1) and disease/treatment related ( Table 2) characteristics except that the women in IG were younger than those is CG (p = .01).

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.
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 " At baseline, there were no between-group differences in terms of demographic (Table 1) and disease/treatment related ( 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 Everyone allocated to intervention group all received the app intervention. so we do not analyze this.

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).
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) subitem not at all important 1 2 3 4 5 essential 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 "An intention-to-treat analysis was conducted using a mixed-effects model analysis using SPSS (V. 24) with signiPcance at p < .05." 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 Please see the table 3~5, we provide this information.
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).
17b) For binary outcomes, presentation of both absolute and relative e&ect sizes is recommended 18) Results of any other analyses pe'ormed, including subgroup analyses and adjusted analyses, distinguishing pre-speci!ed from exploratory 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 We only provide intervention for one time use.
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 We do not have the binary outcomes.
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 No, we do not have this kind of of outcomes to be analyzed.

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 18-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 It depend on the purpose of the study.
Does your paper address CONSORT subitem 19? * 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 provide all outcomes no matter it effective or not. 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 put it in our other published feasibility 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).

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.
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 Since our control group also received alternative intervention. We did not discuss this kind of bias

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations

OTHER INFORMATION
Does your paper address subitem 21-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 "women losing follow-ups is usually due to the fact that they would like to search a second opinion in other hospitals. Even though the attrition rate is not higher (17%), a relatively small sample size may underestimate the effects of this study. Second, since one surgical technique was only familiar to one breast surgeon, inclusion of a single breast surgeon in one medical center limits this study's generalization.

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 No, we use it in the clinical practice.
2021/10/19 11'29 CONSORT-EHEALTH V 1.6.1 -Submission/Publication Form 54/57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 " The protocol was registered at ClinicalTrials.gov [NCT04190992], 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 " https://clinicaltrials.gov/ct2/show/NCT04190992" 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 " The authors would like to thank the Ministry of Science and Technology for funding support (grant #106-2314-B-006-010-MY2). "

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 " Connict of Interest: None declared" As a result of using this checklist, did you make changes in your manuscript? * 2021/10/19 11'29 CONSORT-EHEALTH V 1.6.1 -Submission/Publication Form 56/57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimqc…hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full yes no yes no What were the most impo"ant changes you made as a result of using this checklist?
We added more information in limitation How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * We spend more than 1 hour to change the manuscript.
As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group? This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document