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

NCT07930715, Not applicable, Not yet recruiting, University College Dublin

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleFeasibility Trial of a Culturally Tailored Resilience Intervention for Underserved Breast Cancer SurvivorsClinicalTrials.gov
NCT numberNCT07930715ClinicalTrials.gov
StatusNot yet recruitingClinicalTrials.gov
PhasesNot applicableClinicalTrials.gov
Enrollment80 participants, estimatedClinicalTrials.gov
Lead sponsorUniversity College DublinClinicalTrials.gov
ConditionsBreast Cancer, Cancer SurvivorshipClinicalTrials.gov
InterventionsBRIGHT Resilience Intervention, BRIGHT Survivorship Resource BookletClinicalTrials.gov
First posted2026-11-12ClinicalTrials.gov
Last updated2026-11-12ClinicalTrials.gov

Registered outcomes 11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryRecruitment RateFrom start to end of recruitment, up to 6 monthsNumber of participants randomised per site per month. Progression target: at least 4 participants per site per month.ClinicalTrials.gov
PrimaryRetention3 months after the end of the interventionPercentage of randomised participants who complete the 3-month follow-up questionnaires. Progression target: at least 80%.ClinicalTrials.gov
PrimarySession AttendanceDuring the 8-week interventionPercentage of the 8 intervention sessions attended by participants in the BRIGHT arm, from attendance records. Progression target: at least 75% session completion.ClinicalTrials.gov
PrimaryIntervention FidelityDuring the 8-week interventionPercentage 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%.ClinicalTrials.gov
PrimaryAcceptabilityWeek 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.
ClinicalTrials.gov
SecondaryDepressive SymptomsBaseline, Week 8 and 3 months after the end of the interventionPatient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27; higher scores mean more severe depressive symptoms.ClinicalTrials.gov
SecondaryAnxiety SymptomsBaseline, Week 8 and 3 months after the end of the interventionGeneralised Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21; higher scores mean more severe anxiety.ClinicalTrials.gov
SecondaryFear of Cancer RecurrenceBaseline, Week 8 and 3 months after the end of the interventionFear of Cancer Recurrence Inventory, Short Form (FCRI-SF). Scores range from 0 to 36; higher scores mean greater fear of recurrence.ClinicalTrials.gov
SecondaryCancer-Specific Quality of LifeBaseline, Week 8 and 3 months after the end of the interventionFunctional Assessment of Cancer Therapy, Breast (FACT-B). Total scores range from 0 to 148; higher scores mean better quality of life.ClinicalTrials.gov
SecondaryPsychological ResilienceBaseline, Week 8 and 3 months after the end of the interventionConnor-Davidson Resilience Scale (CD-RISC). Higher scores mean greater resilienceClinicalTrials.gov
SecondaryUnmet Supportive Care NeedsBaseline, Week 8 and 3 months after the end of the interventionSupportive Care Needs Survey, Short Form (SCNS-SF34). Domain scores range from 0 to 100; higher scores mean greater unmet need.ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource

Source 4

FieldValueSource
Releasetrials-2026-11-12-0.3.0ClinicalTrials.gov
Release manifest SHA-2564a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.3.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.