Effects of a WeChat-Based Life Review Program for Patients With Digestive System Cancer: 3-Arm Parallel Randomized Controlled Trial

Background Patients with digestive system cancer often experience psychospiritual distress. Life review is an evidence-based psychological intervention for patients with cancer, but the effects of digital life review programs are unclear, especially for patients with digestive system cancer. Objective We examined the effects of a WeChat-based life review program on the psychospiritual well-being of patients with digestive system cancer. Methods This study was a 3-arm parallel randomized controlled trial. Eligible patients with digestive system cancer were recruited from a university hospital in Fujian, China. They were randomized to a life review group and 2 control groups. All participants received routine care, and the life review group also received the 4-week WeChat-based life review program. Control group 1 also received a 4-week program of friendly visiting. Anxiety, depression, hope, and self-transcendence were measured at baseline and 2 days, 1 month, and 6 months after the intervention. Results A total of 150 participants were randomly allocated to the WeChat-based life review group (n=50), control group 1 (n=50), or control group 2 (n=50). The overall dropout rate was 10% (15/150), and 92% (46/50) of participants in the the life review group completed the intervention. Significant interaction effects for time and group membership were found for anxiety (P<.001), depression (P<.001), hope (P<.001), and self-transcendence (P<.001) at all follow-up time points. For anxiety and depression, the scores did not differ significantly between the life review group and control group 1 on day 2 (P=.80 for anxiety, P=.51 for depression), but the scores were significantly lower in the life review group at month 1 and month 6 (P=.02 for anxiety at both months 1 and 6; P=.003 and P<.001 for depression at months 1 and 6, respectively). Significant increases in hope and self-transcendence were revealed in the life review group compared to control group participants at all follow-up sessions. Conclusions The WeChat-based life review program was effective in reducing anxiety and depressive symptoms and in improving the level of hope and self-transcendence among patients with digestive system cancer. Though friendly visiting can also help to relieve anxiety, its effects are short-term. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17011998; https://tinyurl.com/5acycpd4

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scienti c societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed 其他: 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 o ine 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.  e  a  t  u  r  e  s  /  f  u  n  c  t  i  o  n  a  l  i  t  i  e  s  /  c  o  m  p  o  n  e  n  t  s  o  f  t  h  e  i  n  t  e  r  v  e  n  t  i  o  n  a  n  d  c  o  m  p  a  r  a  t  o  r  i  n  t  h  e  M  E  T  H  O  D  S  s  e  c  t  i  o  n  o  f  t  h  e  A  B  S  T  R  A  C  T 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. 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 brie y explain why the item is not applicable/relevant for your study

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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). 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 brie y explain why the item is not applicable/relevant for your study Yes. The intervention is "fully automated".  t  o  -f  a  c  e  a  s  s  e  s  s  m  e  n  t  s  i  n  t  h  e  M  E  T  H  O  D  S  s  e  c  t  i  o  n  o  f  t  h  e  A  B  S  T  R  A  C  T Mention how participants were recruited (online vs. o ine), 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 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 brie y explain why the item is not applicable/relevant for your study Yes. Participant were recruited o ine. "Digestive system cancer patients were recruited from a university a liated general hospital's oncology department in Fujian, Southeast China." This was a purely web-based trial and only usergroups that were recruited were accessible to the application. Baseline data were collected o ine while follow-up data were collected online. Anxiety, depression, hope, and self-transcendence were measured at baseline, two days (T1), one month (T2), and six months (T3) after the program. Through the procedure, only the assessor who collected the follow-up data was blind to the assignment." 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 brie y explain why the item is not applicable/relevant for your study Yes. "A total of 150 digestive system cancer patients were randomly allocated to LRG (n = 50) , CG 1 (n = 50) or CG 2(n=50). Overall dropout rate of this study is 8.0%." 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) 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 brie y explain why the item is not applicable/relevant for your study Yes. "There was no signi cant difference in anxiety or depressive symptoms between the life review and controll groups 1 at T1, but anxiety and depression were signi cantly lower in the life review than in the controll groups 1 at T2." 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 brie y explain why the item is not applicable/relevant for your study Yes. "Digital technologies are being increasingly used to promote life review interventions via mobile phones, computers, wearable devices, and social media or applications [9][10][11]. However, telephone-based life review interviews did not provide the opportunity to observe non-verbal cues, such as patients' facial expressions and body language. Besides, high dropout rates and a predominantly White, female, and high income or education sample were reported by Wise et al [13]. Although the virtual environment induced a sense of immersion during the therapeutic interaction and, therefore, enhanced patients' engagement and selfexpression, the program was expensive and there were hardware limitations [14][15][16]." Motivation for the study: "WeChat is a social media platform with high popularity among 200 countries, especially in China, due to its simplicity, convenience, e ciency, and mobility [18]. It allows users to interact asynchronously with each other through text messaging, voice messaging, video conferencing, etc., as well as obtain information and resources from all kinds of WeChat platforms at any time. In 2018, our research team developed a WeChat-based life review program for cancer patients, consisting of e-life review interviews, Memory Prompts, Review Extraction, Mind Space, and E-legacy products [19]. A preliminary study found that the program is acceptable, feasible, and promising in improving the psycho-spiritual well-being of cancer patients [7]. Thus, this study aimed to con rm the effectiveness of the WeChat-based life review program in improving the psycho-spiritual well-being of digestive system cancer patients using a three-arm parallel randomized controlled trial." The comparator in the controll group 1 can partly eliminated the attention bias on life review group and provided solid ndings. 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 brie y explain why the item is not applicable/relevant for your study Yes. Inclusion criteria were as follows: (1) diagnosed with digestive system cancer, (2) aged ≥ 18 years, (3) aware of diagnosis and treatment, (4) able to use WeChat, and (5)  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 brie y explain why the item is not applicable/relevant for your study Yes. Participants need to be "able to use application on Wechat plat for the study." Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), 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 con rmation, phone calls) were used to detect/prevent these.

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Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Participants were recruited from June 2019 to October 2020, with follow-ups ending in April 2021from a university-a liated general hospital's oncology department in Fujian, Southeast China. 310 digestive system cancer patients were assessed for eligibility; only 150 patients met the inclusion criteria and consented to participate in this study. They were randomly allocated to three groups: the life review group (n = 50), the friendly visiting group (n = 50), and the control group (n = 50). A trained research assistant who was blinded to group assignment conducted all data collection. Outcome data were collected at baseline (T0), two days (T1), one month (T2), and six months (T3) after the intervention." 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 brie y explain why the item is not applicable/relevant for your study No. In this study questionnaires were completed o ine at baseline and online during followup interviews. 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 brie y explain why the item is not applicable/relevant for your study No. The intervention content used in the current study was developed by our team and two technology engineers were hired to transfer the content into application. 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 brie y explain why the item is not applicable/relevant for your study

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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 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 brie y explain why the item is not applicable/relevant for your study No, the intervention underwent no major changes during the evaluation process. 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 brie y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, We provide the screenshots of our application.

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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. 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 brie y explain why the item is not applicable/relevant for your study Yes." Participants who were allocated received the URL of the application through WeChat. They can use the application as long as they sign up. An assistant will assist with registering and activating the intervention. The application is free and they were provided a Wechat identi cation and password which they could log in with." "Before the intervention, participants in the life review group installed WeChat and created a personal account. They accessed the memory prompts module to obtain an overview of the current session. Then, an e-life review interview was arranged by means of video call with additional instant text, voice message, and emoticons. During the life review process, the facilitator monitored participants' physical condition, emotional status, and responses to the guiding questions. Participants were also encouraged to access the 24-hour available asynchronous communication modules to freely review their interview content, express feelings and blessings, and provide important pictures and e-legacy products. " 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 brie y explain why the item is not applicable/relevant for your study Yes. "The e-life review consisted of an individual, online, 40-to-60 minute interview on WeChat, including four sections.The controll group 1 received four sessions on an individual basis, which provided social contact by engaging participants in daily conversation without reviewing the past. The control group 2 received routine care including drug treatment, nutritional support, symptom management, health education, and functional exercise." 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). 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 brie y explain why the item is not applicable/relevant for your study Yes."One hundred fty non-repeating, random number sequences were generated via the research randomizer website (https://www.randomizer.org/). The numbers ranged from 1 to 150, with 1-50, 51-100, and 101-150 referring to the life review, friendly visiting, and control groups, respectively. Each number was separately packaged in sequentially sealed and opaque envelopes to ensure allocation concealment." 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 brie y explain why the item is not applicable/relevant for your study Yes. "Statistical analysis was performed using R (version 3.5) software, with statistical signi cance set at P < .05. Normally distributed continuous variables were expressed as means and standard deviations, non-normally distributed continuous variables were presented as medians and ranges, and categorical variables were expressed as numbers (percentage). Little's test was adopted to check whether the missing data were missingcompletely-at-random. An intention-to-treat analysis was employed. As for hypothesis testing, chi-square tests, Mann-Whitney U tests, Fisher's exact tests or one-way ANOVA were used to compare the baseline data among groups. Since hierarchical linear model offers more exible data requirements, and accounts for individual change relative to group differences, it was employed for repeated measures. Both the baseline scores (intercepts) and change in scores (linear slopes) for each outcome within the groups were estimated in this model.Time was represented as dummy-coded variables comparing the outcomes at T1 to T0, T2 to T0 and T3 to T0. The effect of life review was examined based on the three dummy-coded time variables and the interaction effects between groups." 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] 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 brie y explain why the item is not applicable/relevant for your study Yes. "An intention-to-treat analysis was employed. Since hierarchical linear model offers more exible data requirements, and accounts for individual change relative to group differences, it was employed for repeated measures." 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 brie y explain why the item is not applicable/relevant for your study Yes. "This study was approved by the Ethics Committee of the Fujian Medical University (IRB Ref. No. 2016/00020) and the study hospital. All participants were provided with detailed information about the study, and written informed consent was obtained from each participant prior to data collection. Importantly, the data collected were kept con dential and anonymous and were used exclusively for this research."  y  a  s  s  i  g  n  e  d  ,  r  e  c  e  i  v  e  d  i  n  t  e  n  d  e  d  t  r  e  a  t  m  e  n  t  ,  a  n  d  w  e  r  e  a  n  a  l  y  s  e  d  f  o  r  t  h  e  p  r  i  m  a  r  y  o  u  t  c  o  m  e   N  P  T  :  T  h  e  n  u  m  b  e  r  o  f  c  a  r  e  p  r  o  v  i  d  e  r  s  o  r  c  e  n  t  e  r  s  p  e  o  r  m  i  n  g  t  h  e  i  n  t  e  r  v  e  n  t  i  o  n  i  n  e  a  c  h  g  r  o  u  p  a  n  d  t  h  e  n  u  m  b  e  r  o  f  p  a  t  i  e  n  t  s  t  r  e  a  t  e  d  b  y  e  a  c  h  c  a  r  e  p  r  o  v  i  d  e  r  i  n  e  a  c  h  c  e  n  t  e  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 brie y explain why the item is not applicable/relevant for your study Yes. "During the period of this study, 310 digestive system cancer patients were assessed for eligibility; only 150 patients met the inclusion criteria and consented to participate in this study. They were randomly allocated to three groups: the life review group (n = 50), the control group 1 (n = 50), and the control group 2 (n = 50 * 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 brie y explain why the item is not applicable/relevant for your study Yes."Fifteen participants withdrew from the study because of disease deterioration (n = 12) or refusal to participate (n = 2), or because they could not be contacted (n = 1). Four of these participants were from the life review group, 6 from the control group 1, and 5 from the control group 2. Finally, 135 participants completed the interventions and measurements." Report multiple "denominators" and provide de nitions: 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 speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention. 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 brie y explain why the item is not applicable/relevant for your study Yes. "Fifteen participants withdrew from the study because of disease deterioration (n = 12) or refusal to participate (n = 2), or because they could not be contacted (n = 1). Four of these participants were from the life review group, 6 from the control group 1, and 5 from the control group 2. Finally, 135 participants completed the interventions and measurements."

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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 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 de nitions 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 de ned (e.g., timeout after idle time) [1] (report under item 6a  D  I  S  C  U  S  S  I  O  N   2  2  )  I  n  t  e  r  p  r  e  t  a  t  i  o  n  c  o  n  s  i  s  t  e  n  t  w  i  t  h  r  e  s  u  l  t  s  ,  b  a  l  a  n  c  i  n  g  b  e  n  e  t  s  a  n  d  h  a  r  m  s  ,  a  n  d  c  o  n  s  i  d  e  r  i  n  g  o  t  h  e  r  r  e  l  e  v  a  n  t  e  v  i  d  e  n  c  e   N  P  T  :  I  n  a  d  d  i  t  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 brie y explain why the item is not applicable/relevant for your study Yes." Our results showed that the WeChat-based life review program could reduce anxiety and depressive symptoms and improve feelings of hope and self-transcendence among digestive system cancer patients for a period of at least six months after the intervention. Our ndings also revealed that friendly visiting might reduce anxiety symptoms in the short term; however, it did not improve depressive symptoms, feelings of hope, and selftranscendence among digestive system cancer patients.Fifteen participants (10%) withdrew at six months of follow-up, which is an attrition rate lower than that of previous online life review studies [13,28] 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 brie y explain why the item is not applicable/relevant for your study Yes. "In addition, the current study increased availability and scalability to this intervention for remotely located patients，promisingly reduced personnel resources for delivery compared with face-to-face interventions. We recommended that future studies should also examine the cost-effectiveness of this program, which would convince facilitators to engage in practice and integrate this intervention into transitional care for cancer patients in community."