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. 2023 Apr 5:33:101126.
doi: 10.1016/j.conctc.2023.101126. eCollection 2023 Jun.

mHealth Coping Skills Training for Symptom Management (mCOPE) for colorectal cancer patients in early to mid-adulthood: Study protocol for a randomized controlled trial

Kelly A Hyland  1 , Grace H Amaden  1 , Allison K Diachina  1 , Shannon N Miller  1 , Caroline S Dorfman  1 , Samuel I Berchuck  2 , Joseph G Winger  1 , Tamara J Somers  1 , Francis J Keefe  1 , Hope E Uronis  3 , Sarah A Kelleher  1
Affiliations

mHealth Coping Skills Training for Symptom Management (mCOPE) for colorectal cancer patients in early to mid-adulthood: Study protocol for a randomized controlled trial

Kelly A Hyland et al. Contemp Clin Trials Commun. .

Abstract

Background: Colorectal cancer (CRC) patients in early to mid-adulthood (≤50 years) are challenged by high symptom burden (i.e., pain, fatigue, distress) and age-related stressors (e.g., managing family, work). Cognitive behavioral theory (CBT)-based coping skills training interventions reduce symptoms and improve quality of life in cancer patients. However, traditional CBT-based interventions are not accessible to these patients (e.g., in-person sessions, during work day), nor designed to address symptoms within the context of this stage of life. We developed a mobile health (mHealth) coping skills training program for pain, fatigue and distress (mCOPE) for CRC patients in early to mid-adulthood. We utilize a randomized controlled trial to test the extent to which mCOPE reduces pain, fatigue and distress (multiple primary outcomes) and improves quality of life and symptom self-efficacy (secondary outcomes).

Methods/design: Patients (N = 160) ≤50 years with CRC endorsing pain, fatigue and/or distress are randomized 1:1 to mCOPE or standard care. mCOPE is a five-session CBT-based coping skills training program (e.g., relaxation, activity pacing, cognitive restructuring) that was adapted for CRC patients in early to mid-adulthood. mCOPE utilizes mHealth technology (e.g., videoconference, mobile app) to deliver coping skills training, capture symptom and skills use data, and provide personalized support and feedback. Self-report assessments are completed at baseline, post-treatment (5-8 weeks post-baseline; primary endpoint), and 3- and 6-months later.

Conclusions: mCOPE is innovative and potentially impactful for CRC patients in early to mid-adulthood. Hypothesis confirmation would demonstrate initial efficacy of a mHealth cognitive behavioral intervention to reduce symptom burden in younger CRC patients.

Keywords: Colorectal cancer; Psycho-oncology; Symptom management; mHealth.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Study flow.
Fig. 2
Fig. 2
Colorectal cancer-related and stage-of-life challenges of patients in early to mid-adulthood.
Fig. 3
Fig. 3
Frames of the study mobile app.
See this image and copyright information in PMC

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