Currently submitted to: JMIR Research Protocols
Date Submitted: Aug 19, 2019
Open Peer Review Period: Aug 21, 2019 - Oct 16, 2019
(currently open for review)
The SEAMLESS Study: Protocol for a clinical trial evaluating a SmartphonE App-based MindfuLnEss intervention for cancer SurvivorS
Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts and geography. Smartphone app-based MBIs are an innovative way to deliver psychosocial cancer-care, and can overcome several such difficulties, since patients can participate at their own convenience. However, while hundreds of mindfulness training apps are commercially available, none have been developed specifically for and rigorously evaluated in cancer survivors.
The SEAMLESS study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship –MBCS– Journey) for treating: 1) symptoms of stress (primary outcome), as well as; 2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). Additionally, the study aims to assess associations between psycho-biometric data collected by the smartphone app with self-reported outcome data from validated psychometric scales. This is the first efficacy trial of a tailored mindfulness app intervention in cancer survivors.
The study design is a randomized wait-list controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all treatments for a minimum of 2 weeks. Outcomes will be assessed online using validated psychometric instruments delivered through the Research Electronic Data Capture (REDCap) survey software at: 1) baseline; 2) mid-intervention (2 weeks later); 3) immediately post-intervention (4 weeks); 4, 5 & 6) at 3, 6 and12 months’ post-baseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. Additionally, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (e.g. angry, elated) from a user-inputted digital emotion-mapping board, and heart-rate data through algorithms that analyze facial bio-signals using photoplethysmography technology.
The study received ethics approval in September, 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome will be complete by September, 2019, and follow-up data will be complete by May, 2020. Data will be analyzed to determine group differences using Linear Mixed Modelling statistical techniques.
Cancer-care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made easily available for psychosocial care at cancer centers worldwide.
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