Effects of a theory-driven, disclosure-based family support programme on fear of cancer recurrence for couples coping with breast cancer: protocol for a multi-centre randomised controlled trial.

BACKGROUND: Breast cancer incidence in women is increasing, although the survival rate remains high. It is regarded as a 'couple disease', with male partners typically the key family member within the household, providing basic care after discharge. Fear of cancer recurrence (FCR) represents a leading unmet need for women with breast cancer and their partners, and evidence has indicated that FCR levels are correlated within couples. Although numerous interventions have focused on women's FCR, relatively few have been designed specifically for partners. Given the interdependent nature of FCR between women and their partners, addressing partners' FCR or adopting a dyadic approach may contribute to reducing women's FCR. Consequently, interventions that actively engage both members of the couple are needed. METHOD: This is a two-arm, parallel-group randomised controlled trial involving 90 couples coping with breast cancer, who will be randomly allocated to receive either the 6-week family support programme delivered via WeChat (n = 45) or 6 weeks of follow-up WeChat calls (n = 45). Outcomes including FCR, social constraints, intrusive thoughts, avoidance, anxiety, and stigma in women with breast cancer and their partners will be assessed at baseline, 6-weeks post-intervention, and 12-week follow-up assessment. Adherence to disclosure within couples and adherence to physical activity and healthy dietary practice in women will be recorded. Independent t-tests and chi-square tests examine the comparability of groups in terms of demographics and disease-related information produced by randomisation. Generalised linear mixed model (GLMM) will be used to evaluate the effectiveness of the family support programme. DISCUSSION: This study will provide rigorous evidence on the effectiveness of the family support programme on FCR for couples coping with breast cancer. Couple-based supportive-oncology programmes, such as the family support programme, that provide educational content on breast cancer-related knowledge, physical activity, healthy diet, psychosocial factors related to breast cancer recurrence, and disclosure in a supportive environment, may be a viable option to reduce FCR, social constraints, and foster cognitive processing for couples coping with breast cancer. This work will address the research gap that limited evidence for interventions that alleviate FCR in women with breast cancer. TRIAL REGISTRATION: ChiCTR2400087252, registered on 23 July 2024, https://www.chictr.org.cn/showproj.html?proj=230362.