A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial

Background Patients with blood cancer experience serious physical and emotional symptoms throughout their cancer journey. Objective Building on previous work, we aimed to develop an app designed to help patients with multiple myeloma and chronic lymphocytic leukemia self-manage symptoms and test it for acceptability and preliminary efficacy. Methods We developed our Blood Cancer Coach app with input from clinicians and patients. Our 2-armed randomized controlled pilot trial recruited participants from Duke Health and nationally in partnerships with the Association of Oncology Social Work, Leukemia and Lymphoma Society, and other patient groups. Participants were randomized to the attention control (Springboard Beyond Cancer website) arm or the Blood Cancer Coach app intervention arm. The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, multiple myeloma and chronic lymphocytic leukemia education resources, and mindfulness activities. Patient-reported data were collected at baseline, 4 weeks, and 8 weeks for both arms through the Blood Cancer Coach app. Outcomes of interest were global health (Patient Reported Outcomes Measurement Information System Global Health), posttraumatic stress (Posttraumatic Stress Disorder Checklist for DSM-5), and cancer symptoms (Edmonton Symptom Assessment System Revised). Among participants in the intervention arm, satisfaction surveys and usage data were used to evaluate acceptability. Results Among 180 patients who downloaded the app, 49% (89) of them consented to participate and 40% (72) of them completed baseline surveys. Of those who completed baseline surveys, 53% (38) of them completed week 4 surveys (16 intervention and 22 control) and 39% (28) of them completed week 8 surveys (13 intervention and 15 control). Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), increasing awareness of resources (73%), and reported being satisfied with the app overall (73%). Participants completed an average of 248.5 app tasks over the 8-week study period. The most used functions within the app were medication log, distress tracking, guided meditations, and symptom tracking. There were no significant differences between the control and intervention arms at week 4 or 8 on any outcomes. We also saw no significant improvement over time within the intervention arm. Conclusions The results of our feasibility pilot were promising in which most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app, and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improved global mental and physical health over 2 months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly White and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention. Trial Registration ClinicalTrials.gov NCT05928156; https://clinicaltrials.gov/study/NCT05928156

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) 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 "A mobile app to support self-management in patients with multiple myeloma or chronic lymphocytic leukemia: A pilot randomized controlled trial"

1a-ii) Non-web-based components or important 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 n/a 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 "A mobile app to support self-management in patients with multiple myeloma or chronic lymphocytic leukemia: A pilot randomized controlled trial" subitem not at all important 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 "The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, MM and CLL education resources, and mindfulness activities. Patient reported data were collected at baseline, 4, and 8 weeks for both arms through the Blood Cancer Coach app."

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) subitem not at all important 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 "The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, MM and CLL education resources, and mindfulness activities. Patient reported data were collected at baseline, 4, and 8 weeks for both arms through the Blood Cancer Coach app." 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 essential 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 "The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, MM and CLL education resources, and mindfulness activities. Patient reported data were collected at baseline, 4, and 8 weeks for both arms through the Blood Cancer Coach app." 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 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.
(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-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 "The results of our feasibility pilot were promising in that most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improve global mental health and global physical health over two months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly white and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention." subitem not at all important 1 2 3 4 5 essential 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 "MM and CLL have a chronic relapsing remitting course that often requires multiple lines of treatment [6,7]. This increases the potential for disease and treatment related physical symptoms and emotional distress [6][7][8][9]." "Mobile health (mHealth) applications (apps) present exciting opportunities to augment patients' disease self-management and meet needs wherever and whenever they arise in a way that is cost effective, efficient, and convenient." subitem not at all important 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 "Self-management apps have been developed and tested for those with diabetes, chronic lung disease, cardiovascular disease and cancer, including Cancer Distress Coach which informed this study's Blood Cancer Coach app [11][12][13]." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 develop and test a blood cancer app aimed at augmenting self-management for adults living with MM and CLL for acceptability, and preliminary efficacy." 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 "Once developed, we aimed to test the apps acceptability and preliminary efficacy through a two armed randomized pilot clinical trial." subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 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 n/a 3b-i) Bug fixes, Downtimes, Content Changes Bug Pxes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug Pxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have insuenced study design such as staff changes, system failures/downtimes, etc. [2].
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 n/a subitem not at all important 1 2 3 4 5 essential 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 "Our eligibility criteria included having either a MM or CLL diagnosis, being at least 18 years old, being able to read English, owning a smartphone (iPhone, Android) and basic computer/internet literacy."

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 "Our eligibility criteria included having either a MM or CLL diagnosis, being at least 18 years old, being able to read English, owning a smartphone (iPhone, Android) and basic computer/internet literacy." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 web-based 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 "The Blood Cancer Coach app was used to administer informed consent, randomize participants 1:1 to attention control (Springboard Beyond Cancer website) or the Blood Cancer Coach intervention arm, and collect self-reported data via surveys."

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.

4b) Settings and locations where the data were collected
subitem not at all important 1 2 3 4 5 essential 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 "This study was approved by the Duke University IRB (Pro00105025). Patients reviewed study details and indicated their consent within the Blood Cancer Coach App. Patients were encouraged to contact our study team if they had any questions or concerns before consenting and at any time during the study." 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 Blood Cancer Coach app was used to administer informed consent, randomize participants 1:1 to attention control (Springboard Beyond Cancer website) or the Blood Cancer Coach intervention arm, and collect self-reported data via surveys."

4b-i) Report 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.
subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 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 Blood Cancer Coach app was used to administer informed consent, randomize participants 1:1 to attention control (Springboard Beyond Cancer website) or the Blood Cancer Coach intervention arm, and collect self-reported data via surveys."

4b-ii) Report how institutional affiliations are displayed
Report how institutional axliations are displayed to potential participants [on ehealth media], as axliations 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) 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 n/a subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations 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 "Our app development partner Pattern Health is approved by Duke University to participate in research activities including hosting sensitive patient health information (PHI)."

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.
subitem not at all important 1 2 3 4 5 essential 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 "We interviewed 17 blood cancer patients and 13 blood cancer clinicians to refine our Blood Cancer Coach mobile app. Our interviews used a previous app (Cancer Distress Coach) developed by our team as a starting point and explored what functionality would be helpful for the specific self-management needs of blood cancer patients. These interviews resulted in several additions to our app which included, feedback tailored to symptom severity, and the inclusion oof a medication tracking feature with medication reminder notifications. Our Blood Cancer Coach app was developed in partnership with Pattern Health, a digital health platform provider, and was refined iteratively based on feedback from our clinician and cancer survivor partners [24]"

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).
subitem not at all important 1 2 3 4 5 essential 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 n/a

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 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture 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 Authors do not own the source code

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.
subitem not at all important 1 2 3 4 5 essential 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 not a web based application

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-vii? * 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 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 "The fully automated (no external human involvement) Blood Cancer Coach mobile app provides educational content on MM and CLL (treatments, symptom management, and available resources). Participants are prompted to record their emotional distress daily and their symptoms weekly through mobile phone notifications. Participants also have the ability to record distress and symptoms more often. A library of guided meditations is available to help participants manage distress. Tailored feedback is provided to encourage self-management and coach participants to reach out for support when appropriate. Symptom and distress graphs are generated to help participants understand and communicate patterns. The app also features custom medication reminders and a medication log to track adherence to cancer treatment and use of as needed medications." subitem not at all important 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 "Participants are prompted to record their emotional distress daily and their symptoms weekly through mobile phone notifications. Participants also have the ability to record distress and symptoms more often."

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).
subitem not at all important 1 2 3 4 5 essential 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 "The fully automated (no external human involvement) Blood Cancer Coach mobile app ..."

5-xi) Report 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 "Participants are prompted to record their emotional distress daily and their symptoms weekly through mobile phone notifications. Participants also have the ability to record distress and symptoms more often." "The app also features custom medication reminders and a medication log to track adherence to cancer treatment and use of as needed medications." subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) 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 n/a subitem not at all important 1 2 3 4 5 essential 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 "Outcomes were self-reported at baseline, Week 4 and Week 8 through the Blood Cancer Coach app. App usage was assessed at the end of the study period using Pattern Health app usage analytics. For those in the intervention arm, acceptability was measured using a perceived helpfulness and satisfaction survey administered at Week 8. All data collection was done through the Blood Cancer Coach app. essential 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/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 "App usage was tracked by Pattern Health mobile app platform. A date and time stamped log was created when a user began a task (e.g., logging a medication) that further indicated if the task was completed." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "Participants were also invited to provide free text feedback through two prompts, 1. What did you like best about the Blood Cancer Coach App? And 2. How can we change Blood Cancer Coach to make it better?" 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 n/a 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
7b) When applicable, explanation of any interim analyses and stopping guidelines 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 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 n/a 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 n/a 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 "The Blood Cancer Coach app was used to administer informed consent, randomize participants 1:1 to attention control (Springboard Beyond Cancer website) or the Blood Cancer Coach intervention arm, and collect self-reported data via surveys." 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 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 The Blood Cancer Coach app was used to administer informed consent, randomize participants 1:1 to attention control (Springboard Beyond Cancer website) or the Blood Cancer Coach intervention arm, and collect self-reported data via surveys." 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 "The Blood Cancer Coach app was used to administer informed consent, randomize participants 1:1 to attention control (Springboard Beyond Cancer website) or the Blood Cancer Coach intervention arm, and collect self-reported data via surveys." 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential 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 "The Blood Cancer Coach app was used to administer informed consent, randomize participants 1:1 to attention control (Springboard Beyond Cancer website) or the Blood Cancer Coach intervention arm, and collect self-reported data via surveys."

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 "Because our control arm was not a placebo, participants were aware of their group assignment." subitem not at all important 1 2 3 4 5 essential 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) 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectationsdiscuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

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 "Because our control arm was not a placebo, participants were aware of their group assignment." 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 not relevant.
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 subitem not at all important 1 2 3 4 5 essential 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 "Descriptive statistics were used to summarize participant characteristics across study arms. Results of the perceived helpfulness and satisfaction survey results were summarized with means (SD). Further the percentage of those endorsing Likert scale ratings of 3 (moderately satisfied/moderately helpful) were reported. Acceptability will be determined if greater than 70% report overall satisfaction of moderate or better. Free text answers to the perceived helpfulness and satisfaction survey were narratively summarized to gain further insight into acceptability. We will also describe usage rates of the app overall and by task type. Independent t-tests were used to compare change from baseline to Week 4 between intervention and control arms. Paired t-tests were used to compare score changes from baseline to Week 4 and from baseline to Week 8 in participants of the intervention arm. Effect sizes were estimated using Cohen's d.
[23]" 12a-i) Imputation techniques to deal with attrition / 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]). subitem not at all important 1 2 3 4 5 essential 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 No imputation methods used.
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 no additional analyses.

X26-i) Comment on ethics committee approval
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-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 "This study was approved by the Duke University IRB (Pro00105025). "

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained orine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

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 "Patients reviewed study details and indicated their consent within the Blood Cancer Coach App. Patients were encouraged to contact our study team if they had any questions or concerns before consenting and at any time during the study." subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants 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

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 "Our app development partner Pattern Health is approved by Duke University to participate in research activities including hosting sensitive patient health information (PHI). PHI collected through the app include, name, age in years, email address and date of MM or CLL diagnosis. All data was encrypted in transit and at rest on Pattern Health servers. Data stored locally on participants mobile devices was encrypted by the Pattern Health App. Study team access to user data was password protected and limited to authors MRL, SKS, and JM. All data analysis was conducted on deidentified data." 13b) For each group, losses and exclusions after 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 "Among 180 patients who downloaded the app, 89 (49%) consented to participate, and 72 (40%) completed baseline surveys. Of those who completed Baseline surveys, 38 (53%) completed Week 4 (16 intervention, 22 control) surveys and 28 (39%) completed week 8 surveys (13 intervention and 15 control) (Figure 1). Demographics are reported for those who completed Week 4 surveys (Table 1)." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow 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 Outlined in Figure 1.
subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up 13b-i) Attrition 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 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 "Recruitment and enrollment occurred between December 2020, and October 2021. Participants were followed for 8 weeks following enrollment." 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) 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 to report.
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 n/a 15) A essential 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 See Table 1.

15-i) Report 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 "Our sample was 50% female, 90% non-Hispanic white, 79% college educated, and 8% reported income less than $30,000" Also see Table 1.
16) For each group, number of participants (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 16-i) Report multiple "denominators" and provide definitions 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 "Of the 16 intervention arm participants 15 completed our perceived helpfulness survey. Almost 3 quarters (11/15, 73%) reported at least moderate satisfaction with the app. (Table  2) Additionally, most participants found the app at least moderately effective at: helping manage symptoms (13/15, 87%), feeling more comfortable seeking help (13/15, 87%), and increasing awareness of resources (11/15, 73%)." subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence 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 n/a 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 see subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect 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 "Participants in the intervention arm completed an average of 148.5 (SD 118.6) app tasks during the 8 week study period and app usage ranged from 11 to 518 tasks completed. The most used functions within the app as measured my mean usage across participants were the medication log (66.1, SD 76.3), distress tracking (47.1, SD 25.5), and daily tips (mean 12.9, SD 21.5)." 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified 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 n/a 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 n/a

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).

19) All important harms or unintended effects in each group
(for speciPc guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential 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 n/a 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 No unintended harms arose during the trial.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 19-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 No privacy breaches arose during the trial 19-ii) Include qualitative feedback from participants or observations from staff/researchers Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.
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 "Regarding the open-ended questions soliciting user satisfaction and perceived helpfulness, 4/15 (27%) participants cited the guided meditations and daily inspirational quotes as the best parts of the app, 3/15 (20%) cited the ability to see how things change day by day, and 3/15 (20%) said they appreciated the medication tracking and reminders. 3 out of 15 (20%) participants suggested changes in the way the app functioned such as adding the ability to edit previous days entries. 2 out of 15 (13%) mentioned that they themselves were not experiencing many symptoms and thought the app might be more helpful for those with higher burdens of physical symptoms and emotional and distress."

22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting 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? * 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 this study we aimed to develop and pilot test a mobile health app to help blood cancer patients self-manage physical and emotional symptoms. Through an iterative process in partnership with clinicians and blood cancer patients we developed the Blood Cancer Coach mobile app for testing of acceptability and preliminarily efficacy. " subitem not at all important Does your paper address subitem 22-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 "Future studies should target participants with moderate to high levels of symptom burden and distress and include self-efficacy as an outcome." "Like other mHealth studies, our study sample was overwhelming white and highly educated (Table 1) [11,14]. This is problematic for several reasons, among them that racial minorities and those with lower socioeconomic status (SES) consistently report worse health outcomes than their White peers and those with higher SES [26,27]. Our trials are not reaching the patient populations that might need have the greatest need for emotional and physical symptom management, robbing us of evidence in these populations with high needs. A more targeted recruitment strategy focusing on underserved cancer patient populations is warranted." subitem not at all important 1 2 3 4 5 essential 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial Pndings according to the intervention, comparators, patients, and care providers or centers involved in the trial

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 "We also experienced significant attrition as only 39% of participants completed the Week 8 surveys (i.e., all planned data collection). These low response rates introduce potential bias if those who respond are systematically different from those who do not respond. Like other mHealth studies, our study sample was overwhelming white and highly educated (Table 1)  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 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 Your answer 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting 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.

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 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 not applicable. Our intervention was designed to be fully automated and self contained 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 n/a 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential 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 n/a 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 Funding: This study was supported by the Association of Oncology Social Work 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.
About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no 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 "Conflicts of Interest: None" As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?

Your answer
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Any other comments or questions on CONSORT EHEALTH Your answer