Clinical trial · Interventional
RCT of a Group Intervention for Women With a Family History of Breast Cancer
A Randomized Controlled Trial of a Group Intervention for Women With a Family History of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
One in 10 Canadian women will be diagnosed with breast cancer (BC) and approximately 5% of all BC is believed to be hereditary. Women with a family history experience high levels of perceived risk for developing BC. Elevated risk perceptions for BC have been associated with psychological distress, which, in turn, can interfere with screening adherence. In our completed CBCRI-funded study, we developed and standardized a group intervention designed to address the psychological issues associated with having a family history of BC. Results demonstrated that the intervention led to significant improvement in levels of anxiety and depression, improved BC risk factors/genetics knowledge and was associated with optimal screening behavior. The proposed study will rigorously test the group intervention in comparison to standard risk counselling in a sample of 150 women recruited from Familial BC clinics in Toronto. The interventions will be examined for their impact on a) psychological functioning, b) BC risk/genetic knowledge and c) screening behaviors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supportive-Expressive Group Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Psychosocial functioning (using standardized instruments)
- timeFrame
- 1 year
- measure
- Breast Cancer risk/genetic knowledge
- timeFrame
- 1 year
- measure
- Screening behaviors
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- Post Traumatic Growth
- timeFrame
- 1 year
- measure
- Cost effectiveness
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * at least one 1st-degree relative with Breast Cancer * age 18-70 years * live within one hour of downtown Toronto * score higher than 15 in Breast Cancer Anxiety Scale (BCAS) Exclusion Criteria: * Carrier status for genetic mutation (i.e. BRCA1) known * Previous diagnosis of breast cancer or other malignancy (other than non-melanoma skin cancer) * History of major psychiatric disorder, such as schizophrenia, active psychosis, untreated major depression, as defined in the DSM IV and obtained through a semi-structured psychiatric interview * Failure to provide informed consent
References
Publications (0)
Data not yet available