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

November 5, 2026 updated by: Sinem Uzar Ozcetin, University College Dublin

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: From start to end of recruitment, up to 6 months

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
Time Frame: 3 months after the end of the intervention

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
Time Frame: During the 8-week intervention

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
Time Frame: During the 8-week intervention

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
Time Frame: Week 8 (end of the intervention)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depressive Symptoms
Time Frame: Baseline, Week 8 and 3 months after the end of the intervention

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
Time Frame: Baseline, Week 8 and 3 months after the end of the intervention

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
Time Frame: Baseline, Week 8 and 3 months after the end of the intervention

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
Time Frame: Baseline, Week 8 and 3 months after the end of the intervention

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
Time Frame: Baseline, Week 8 and 3 months after the end of the intervention

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
Time Frame: Baseline, Week 8 and 3 months after the end of the intervention

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College Dublin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Breast Cancer Now

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2029

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings