The SERENITY study: online Mindfulness-Based Cancer Recovery (e-MBCR) program for women living with breast and gynecological cancer—protocol for a pilot effectiveness-implementation randomized trial

ABSTRACT Background: Mindfulness-Based Interventions (MBIs) have been shown to improve mental and physical health as well as biological processes of patients living with cancer. More research is needed to inform on the determinants that might facilitate or hinder their implementation in hospitals. The primary objective of this study was to explore the feasibility and implementation of an online Mindfulness-Based Cancer Recovery program (e-MBCR) for women with breast and gynecological cancer treated at two academic oncology centers in Switzerland. The secondary objective was to explore the psychological and biological effects of the program. Methods: The SERENITY study is a pilot hybrid effectiveness-implementation trial using a randomized waitlist-controlled design, including a mixed methods approach. The intervention groups receive treatment as usual and the e-MBCR program, whereas the control groups are on a wait-list to receive an online Mindfulness-Based Stress Reduction program at the end of the study. Four e-MBCR programs are delivered consecutively, with 12 patients in each group. Participants' attendance to the sessions is the primary outcome. Implementation outcomes of interest are feasibility, acceptability, appropriateness, fidelity, costs, and early sustainability. Implementation determinants will be described, and an exploratory analysis of psychological outcomes and cancer-related biomarkers will be performed at three time points (baseline, postintervention, and 3 months of follow-up). Discussion: The results of this study will inform a future large trial and adjustments needed for a real-world implementation of the program. The translational part of this study will contribute to the collective effort to better understand how MBIs affect important cancer-related biomarkers.