Family communication-focused family resilience-strengthening program for young and middle-aged breast cancer survivors: Protocol for a pilot randomized controlled trial (Preprint)

BACKGROUND Breast cancer, the most common form of cancer among women, is a family affair, impacting the psychosocial outcomes, quality of life, and family stability of young and middle-aged survivors and their spouses primarily. Family resilience-oriented intervention has been proposed as an effective strategy to improve the health of breast cancer survivors and their spouses. However, family resilience-oriented clinical intervention programs and implementation interventions are in the initial stages of exploration. Furthermore, communication-related problems, which are prevalent in families with cancer, are barriers to the creation and strengthening of family resilience. OBJECTIVE To report a pilot study protocol to validate the effectiveness of a family resilience-strengthening program for young and middle-aged breast cancer survivors, a web-based intervention that focuses specifically on communication issues for survivors and their families, called the Family Communication-focused Family Resilience-strengthening Program. METHODS A pilot double-blind, randomized controlled trial using a two-group, pre-test and repeated post-test design. The trial will enroll 78 families of breast cancer survivors who will be randomly assigned in a 1:1 ratio to an intervention group and a waiting control group. The intervention group will receive the 5-week Family Communication-focused Family Resilience Strengthen Program immediately, while the control group will receive treatment at the end of the trial. Outcomes will be assessed at baseline, post-intervention, one month post-intervention, and three months post-intervention for both study groups. RESULTS The primary outcome indicator is family resilience for survivors and spouses, and the secondary outcome indicators are psychological distress, quality of life, post-traumatic growth, spousal intimacy for survivors and spouses, and spousal-reported child emotional-behavioral outcomes. CONCLUSIONS If the program proves effective, it will be the first full-component, multimember-based family resilience-strengthening program focusing on family communication for breast cancer survivors. Web-based family resilience strengthening programs that focus on family communication can be a convenient and quick way to strengthen family resilience and guide families to better cope with illness. CLINICALTRIAL China Clinical Trial Registry ChiCTR2100044835.