Abstract
BackgroundCancer 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.ObjectiveThe SEAMLESS (Smartphone App–Based Mindfulness Intervention for Cancer Survivors) 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). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors.MethodsThis is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology.ResultsThe 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 time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques.ConclusionsCancer 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 available for psychosocial care at cancer centers worldwide.Trial RegistrationClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000International Registered Report Identifier (IRRID)DERR1-10.2196/15178
Highlights
BackgroundPrevious research suggests that cancer survivors in Canada have several unmet psychosocial needs after completing treatments, which differ from patients newly diagnosed or undergoing treatment [1]
This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am Mindfulness-Based Cancer Survivorship (MBCS) for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments
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
Summary
BackgroundPrevious research suggests that cancer survivors in Canada have several unmet psychosocial needs after completing treatments, which differ from patients newly diagnosed or undergoing treatment [1]. Almost half of all cancer survivors experience symptoms from late and long-term effects of treatments such as fatigue, pain, and distress [2]. They must deal with psychosocial stressors such as anxiety, depression, uncertainty about the future, and fear of cancer recurrence as they transition back to their previous roles and responsibilities at home and in the workplace; these factors can impair their quality of life, performance at work, and their ability to contribute to society [3,4]. FCRI contains 42 items, evaluating 7 components associated with the fear of cancer recurrence: triggers, severity, psychological distress and functioning impairments, insight scale, reassurance, and coping strategies. Total score can be obtained from each subscale and a total FCRI score can be obtained by adding the total scores of all subscales, higher scores indicate higher levels of fear of cancer recurrence
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