An interventional study of BRIGHT Resilience Intervention and BRIGHT Survivorship Resource Booklet in Breast Cancer and Cancer Survivorship, sponsored by University College Dublin. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University College Dublin · Not applicable, Interventional, and Supportive care
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:
Participants will:
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 80 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University College Dublin is the lead sponsor of 114 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants attend the 8-week culturally tailored BRIGHT resilience intervention: weekly 90-minute
Behavioral: BRIGHT Resilience Intervention
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
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.
BRIGHT Survivorship Resource Booklet A printed resource booklet with survivorship information and signposting to support services, given alongside standard oncology survivorship care.
Recruitment Rate
Number of participants randomised per site per month. Progression target: at least 4 participants per site per month.
Time frame: 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%.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: Week 8 (end of the intervention)
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27; higher scores mean more severe depressive symptoms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, Week 8 and 3 months after the end of the intervention
No study locations are listed for this record.
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2029; primary completion for Sep 2030, 11 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 11 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.