Study protocol for the Coping After Breast Cancer (CABC) trial: A randomized controlled trial of stress management e-health interventions (Preprint)

UNSTRUCTURED One-third or more of breast cancer survivors report stress and other psychological and physical complaints that can negatively impact quality of life. Psychosocial stress-management interventions, shown to mitigate the negative impact of these complaints, can now be delivered as accessible and convenient (for the patient and provider) e-health interventions. In the present randomized controlled trial (RCT), Coping After Breast Cancer (CABC), two modified versions of the stress management e-health intervention program StressProffen were created: one with predominantly cognitive-behavioral stress-management content (Stressproffen-CBI) and one with predominantly mindfulness-based stress-management content (StressProffen-MBI). The aim is to investigate the short- and long-term effects in breast cancer survivors of using StressProffen-CBI and StressProffen-MBI compared to a control group (treatment as usual). Methods: Women diagnosed with breast cancer (stage I-III, unequivocally HER2+ or ER- tumors) or DCIS aged 21-69 years who completed the Cancer Registry of Norway- initiated health survey on quality of life, are invited to the CABC trial about seven months after diagnosis. Women who give consent to participate are randomized (1:1:1) to: Stressproffen-CBI, Stressproffen-MBI, or control group. Both Stressproffen interventions consist of 10 modules of stress management content delivered through text, sound, video, and images. The primary outcome is between-groups changes in perceived stress at six months, assessed with Cohen’s Perceived Stress Scale. Secondary outcomes comprise changes in quality of life, anxiety, depression, fatigue, sleep, neuropathy, coping, mindfulness and work-related outcomes approximately 1, 2 and 3 years after diagnosis. Long-term effects of the interventions on work participation, comorbidities, relapse or new cancers and mortality will be obtained from national health registries. We plan to recruit 430 participants, and recruitment is scheduled from January 2021 to late spring 2023. In summary, the ongoing CABC trial is possibly the largest ongoing psychosocial e-health RCT in breast cancer patients at current. If one or both interventions prove to be effective in reducing stress and improving psychosocial and physical complains, the StressProffen e-health interventions could be beneficial, inexpensive and easily implementable tools for breast cancer survivors when coping with late effects after cancer and cancer treatments. Trial registration: Clinicaltrials.gov identifier NCT04480203.