A Smartphone App-Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial.

BACKGROUND: 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. OBJECTIVE: The 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. METHODS: This 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. RESULTS: 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 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. CONCLUSIONS: 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 available for psychosocial care at cancer centers worldwide. TRIAL REGISTRATION: ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15178.

The ONE-MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness-based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy.

Cancer patients often experience poor quality of life (QoL) during chemotherapy (CT) treatments due to side effects including fatigue, insomnia, pain and nausea/vomiting. Mindfulness-based cancer recovery (MBCR) is an evidence-based intervention for treating such symptoms, but has not been investigated as an adjunctive treatment during CT. This study aims to determine the efficacy of an online group MBCR programme delivered during CT in 12 real-time interactive weekly sessions for managing fatigue (primary outcome). Secondary outcomes include sleep disturbance, pain, nausea/vomiting, mood, stress and QoL. Exploratory outcomes include cognitive function, white blood cell counts and return to work. The study is a two-armed randomised controlled waitlist trial with 2:1 allocation to treatment (online group MBCR during CT) or control (waitlist usual care; online MBCR following CT completion) with a target sample size of N = 178. Participants are breast or colorectal cancer patients undergoing common CT regimens in Calgary, Canada. Online assessments using validated self-reported instruments will take place at baseline, post-MBCR, post-CT and 12 months' post-baseline. If online MBCR delivered during CT significantly reduces fatigue in cancer patients' post-CT and also impacts secondary symptoms, this would provide evidence for including mindfulness training as an adjunctive symptom management therapy during CT.

Psychosocial therapies for patients with cancer: a current review of interventions using psychoneuroimmunology-based outcome measures.

BACKGROUND: As part of a new standard of quality cancer care, the Institute of Medicine has recommended inclusion of therapies that address psychosocial needs of cancer patients. A range of psychosocial therapies for managing acute and chronic stress have been developed for patients with cancer, based on the scientific framework of psychoneuroimmunology (PNI). The current review aimed to identify studies of new and emerging PNI-based psychosocial therapies in patients with cancer that have used neuroendocrine-immune biomarkers as outcomes. Specifically, this review aimed to evaluate studies based on the cancer populations involved, types of psychosocial therapies, and PNI measures employed. METHOD: Methodology was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The PubMed, EMBASE, PsychINFO, CINAHL, and Google Scholar online databases were searched using combinations of keywords obtained from previous reviews of psychosocial interventions. Studies from 2001 to 2012 were included if they ( : ) were published in English, ( : ) used experimental or quasi-experimental designs, ( : ) evaluated psychosocial therapies, ( : ) involved cancer patients, and ( : ) reported results on at least one neuroendocrine or immune outcome measure. The search strategy identified 403 records and 2 stages of screening were used to eliminate irrelevant studies. RESULT: A total of 24 cancer-specific studies of psychosocial therapies that used PNI-based outcome measures were included in this review. Most studies included early-stage breast cancer patients, and 2 major types of therapies emerged, cognitive-behavioral therapies and complementary medical therapies. Durations of interventions ranged widely, from 1.3 hours over a single week to 27 hours over 18 weeks. Considerable diversity in PNI outcomes made statistical comparisons problematic. Studies of cognitive-behavioral therapies were found to have reported the most success in impacting PNI-based measures, which were typically functional measures of the immune system, for example, cytokines. CONCLUSION: Several issues related to research methodology are discussed. Most important, studies examining dose-response associations and resource allocation are needed to guide future research. A standardized panel of psychosocial instruments and biomarkers for PNI-based studies would enhance comparability of findings across studies when evaluating this body of research and assist with integrating psychosocial therapies into the standard of cancer care.