Testing two digital stress-management interventions in a randomized controlled trial of breast cancer patients

The digital stress-management intervention StressProffen has been shown to be associated with improved well-being and quality of life for cancer survivors. In the Coping After Breast Cancer (CABC) trial, effects of 6 months' access to modified versions of StressProffen, delivered through a digital download-only model, were examined. Women with breast cancer were invited to participate in the trial 6-9 months following diagnosis. Eligible participants were randomized to either: (1) digital cognitive behavioral therapy stress-management intervention (CBI), n = 140, (2) digital mindfulness-based stress-management intervention (MBI), n = 143, or (3) usual-care (control group), n = 147. Primary outcome was change in perceived stress level (PSS-10), while secondary outcomes included changes in health-related quality of life (HRQoL), anxiety and depression, fatigue, mindfulness, sleep and coping. Perceived stress level at baseline was low for all groups. No statistically significant mean differences (MD) were detected between either of the intervention groups and the control group from baseline to 6-month follow-up for perceived stress level (MBI: MD -0.28 [95%CI: -1.75, 1.19], CBI: MD -0.42 [95%CI: -1.89, 1.06]), nor for the majority of the secondary outcomes. After 6 months of access, the CBI and MBI stress-management interventions did not yield significantly improved outcomes for women with breast cancer compared with usual-care controls. Further explorations of which interventions and delivery models may optimize use and effect, best timing for delivery, and individual preferences are needed. ClinicalTrials.gov identifier NCT04480203.