Feasibility Trial of a Culturally Tailored Resilience Intervention for Underserved Breast Cancer Survivors (BRIGHT)

Background: Women from underserved communities in Ireland often experience higher psychological distress, fear of cancer recurrence, unmet supportive care needs and barriers to survivorship services. Few psychosocial survivorship interventions have been designed or culturally adapted for these groups.

Intervention development: The BRIGHT resilience intervention is being developed in earlier stages of Project BRIGHT, a 42-month mixed methods study submitted for funding to Breast Cancer Now. These stages include a national survey of breast cancer survivors, interviews with women from underserved communities and a structured co-design process with survivors, clinicians, researchers and community stakeholders. Cultural adaptation is guided by Resnicow's Cultural Adaptation Framework and documented using FRAME.

Intervention: An 8-week hybrid programme of weekly 90-minute facilitated group sessions, delivered face to face in the community and through secure online sessions, with a participant workbook. Planned modules, subject to the co-design findings, are psychoeducation; emotional adjustment; managing fear of recurrence; culturally responsive coping and resilience; self-advocacy; healthcare navigation; peer support; and signposting to community resources. Materials will be translated into 2 to 3 priority languages.

Design: A two-arm parallel feasibility randomised controlled trial with 80 participants, individually randomised 1:1. A computer-generated, concealed allocation sequence will be managed by an independent researcher not involved in recruitment or intervention delivery. The comparator is usual survivorship care plus the BRIGHT Survivorship Resource Booklet, with delayed access to the BRIGHT programme after the 3-month follow-up (waitlist crossover). Allowing for up to 25% attrition, at least 60 participants are expected to be evaluable at final follow-up.

Data collection: Questionnaires at baseline (T0), after the intervention (T1, Week 8) and 3 months after the intervention (T2).

Progression criteria: Progression to a definitive trial will be guided by pre-specified traffic light criteria: at least 80% retention, at least 75% session completion, at least 85% intervention fidelity and a recruitment rate of at least 4 participants per site per month.

Process evaluation: Guided by the MRC Process Evaluation Framework, semi-structured interviews with 15 to 20 participants and facilitators will explore acceptability, barriers and facilitators to implementation, mechanisms of impact, fidelity and context. Fidelity will be assessed using facilitator session checklists, attendance records and independent review of a sample of recorded sessions.

Analysis: Feasibility outcomes will be reported using descriptive statistics with 95% confidence intervals. Exploratory analyses of secondary outcomes will estimate effect sizes and variance to inform the sample size for a future definitive trial.