Feasibility and preliminary effects of a coping-focused dyadic family resilience intervention for breast cancer patients and their family caregivers: a pilot study
JS Gao, Qin Shen, Pei Sun, Xiao Zhang, Hui Li, Chun-Ping Ni
Objective This pilot randomized controlled trial evaluated the feasibility and preliminary effects of a Coping-Focused Dyadic Family Resilience Intervention (CFFRI) for Chinese breast cancer survivor-caregiver dyads. Methods A randomized, single-blind controlled trial was conducted. Sixty dyads were randomly assigned to the CFFRI group (six sessions plus usual care; n = 30) or the control group (usual care alone; n = 30). Outcomes included family resilience, coping style, family disease burden, and social support, assessed at baseline (T0), one-week post-intervention (T1), and three-month follow-up (T2). Data were analyzed using t -tests and generalized estimating equations (GEE). Feasibility was assessed via recruitment, retention, and adherence rates, and intervention satisfaction. Results For the primary outcome, family resilience, the between-group mean difference at T1 was 20.08 (95% CI: 14.61–25.55) for patients and 19.85 (95% CI: 13.65–26.04) for caregivers in the per-protocol analysis, with effects sustained at T2 (patients: 14.69, 95% CI: 10.71–18.68; caregivers: 15.73, 95% CI: 11.08–20.38). Similar patterns were observed in intention-to-treat analyses. For secondary outcomes, the CFFRI group showed improvements in coping style, reduced family disease burden, and enhanced social support. Feasibility outcomes were favorable: recruitment rate 75.00%, retention rate 91.67%, high adherence rate 90.00%, and mean satisfaction score of 4.52 (SD = 0.57) out of 5. Conclusion The CFFRI is a feasible intervention that shows promise in enhancing family resilience, improving dyadic coping, alleviating family disease burden, and strengthening social support for both patients and caregivers, with benefits sustained at 3 months. These preliminary findings provide support for its preliminary efficacy and form the basis for a future fully powered randomized controlled trial. Clinical trial registration https://www.chictr.org.cn/showproj.html?proj=135318 , identifier [ChiCTR2100052108].