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

BRIGHT (Breast Cancer Resilience Intervention for Growth, Hope and Thriving): Co-Designing and Feasibility Testing a Culturally Tailored Resilience Intervention for Underserved Breast Cancer Survivors in Ireland

The goal of this feasibility trial is to find out whether a culturally tailored resilience intervention, called BRIGHT, can be delivered and tested with breast cancer survivors from underserved communities in Ireland. These include women from minority ethnic groups (including Travellers), migrant women, women living in rural areas and women experiencing socioeconomic disadvantage.

The main questions it aims to answer are:

• Can enough women be recruited and kept in the study?
• Do women attend the sessions and find the intervention acceptable?
• Can facilitators deliver the intervention as planned? Researchers will compare the BRIGHT resilience intervention with usual survivorship care plus a resource booklet. The results will show whether a larger, definitive trial is possible and will give early signals of benefit for psychological distress, fear of cancer recurrence, resilience, quality of life and unmet supportive care needs.

Participants will:

• Be randomly assigned to the BRIGHT resilience intervention or to usual care plus the BRIGHT Survivorship Resource Booklet
• In the BRIGHT group, attend 8 weekly 90-minute facilitated group sessions, in the community or online
• Complete questionnaires at the start, after 8 weeks and 3 months after the programme ends
• Be invited to take part in an interview about their experience (some participants only) Women in the usual care group will be offered the BRIGHT programme after their final follow-up.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Cancer Survivorship
• Intervention / Treatment: Behavioral: BRIGHT Resilience Intervention; Other: BRIGHT Survivorship Resource Booklet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karina Correa Valdez; Phone Number: +353 0833887830; Email: karina.correavaldez@ucd.ie
• Study Contact Backup: Name: Sinem Uzar Ozcetin Associate Professor in Mental Health Nursing; Email: sinem.uzarozcetin@ucd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women aged 18 years or older.
• Diagnosis of breast cancer stage 0 to III.
• Completed primary treatment (surgery, chemotherapy and/or radiotherapy)
• Belong to at least one underserved group: minority ethnic group (including Irish Travellers), migrant or refugee, living in a rural area, or experiencing socioeconomic disadvantage.
• Living in Ireland
• Able to give informed consent, with interpreter support if needed
• Able to attend group sessions face to face or online

Exclusion Criteria:

• Metastatic (stage IV) breast cancer
• Severe mental health or cognitive difficulties that would prevent taking part in group sessions.
• Currently taking part in another psychosocial intervention study
• Took part in the BRIGHT co-design panel or user testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRIGHT Resilience Intervention; Participants attend the 8-week culturally tailored BRIGHT resilience intervention: weekly 90-minute	Behavioral: BRIGHT Resilience Intervention; A culturally tailored, co-designed group resilience programme for breast cancer survivors from underserved communities. Eight weekly 90-minute facilitated sessions, delivered in a hybrid format (community face to face and secure online). Planned modules: psychoeducation; emotional adjustment; managing fear of recurrence; culturally responsive coping and resilience; self-advocacy; healthcare navigation; peer support; and signposting to community resources. Delivered by trained facilitators using a standardised manual. Materials available in English and 2 to 3 priority languages.
Active Comparator: Enhanced Usual Care; Participants receive standard oncology survivorship care plus the BRIGHT Survivorship Resource Booklet. They are offered the BRIGHT resilience intervention after the 3-month follow-up (waitlist crossover).	Other: BRIGHT Survivorship Resource Booklet; BRIGHT Survivorship Resource Booklet A printed resource booklet with survivorship information and signposting to support services, given alongside standard oncology survivorship care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Number of participants randomised per site per month. Progression target: at least 4 participants per site per month.	From start to end of recruitment, up to 6 months
Retention	Percentage of randomised participants who complete the 3-month follow-up questionnaires. Progression target: at least 80%.	3 months after the end of the intervention
Session Attendance	Percentage of the 8 intervention sessions attended by participants in the BRIGHT arm, from attendance records. Progression target: at least 75% session completion.	During the 8-week intervention
Intervention Fidelity	Percentage of planned session components delivered as intended, assessed using facilitator session checklists and independent review of a sample of recorded sessions. Progression target: at least 85%.	During the 8-week intervention
Acceptability	Participant satisfaction with the intervention, measured using a questionnaire based on the Theoretical Framework of Acceptability, and explored in interviews with 15 to 20 participants and facilitators.	Week 8 (end of the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27; higher scores mean more severe depressive symptoms.	Baseline, Week 8 and 3 months after the end of the intervention
Anxiety Symptoms	Generalised Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21; higher scores mean more severe anxiety.	Baseline, Week 8 and 3 months after the end of the intervention
Fear of Cancer Recurrence	Fear of Cancer Recurrence Inventory, Short Form (FCRI-SF). Scores range from 0 to 36; higher scores mean greater fear of recurrence.	Baseline, Week 8 and 3 months after the end of the intervention
Cancer-Specific Quality of Life	Functional Assessment of Cancer Therapy, Breast (FACT-B). Total scores range from 0 to 148; higher scores mean better quality of life.	Baseline, Week 8 and 3 months after the end of the intervention
Psychological Resilience	Connor-Davidson Resilience Scale (CD-RISC). Higher scores mean greater resilience	Baseline, Week 8 and 3 months after the end of the intervention
Unmet Supportive Care Needs	Supportive Care Needs Survey, Short Form (SCNS-SF34). Domain scores range from 0 to 100; higher scores mean greater unmet need.	Baseline, Week 8 and 3 months after the end of the intervention

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: Breast Cancer Now

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2029
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: November 5, 2026
• First Submitted That Met QC Criteria: November 5, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 5, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Resilience; Feasibility Study; Health Equity; Psychosocial Intervention; Cultural Adaptation; Fear of Cancer Recurrence; Migrants; Co-Design; Underserved Populations
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2026.06EWPR1135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

A decision on sharing anonymised individual participant data will be made before recruitment starts, in line with University College Dublin policy, funder requirements and GDPR.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No