Clinical trial · Interventional
Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children
- 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)
RATIONALE: A study that evaluates the support of a decision guide used together with genetic counseling may improve communication between mothers undergoing BRCA1/2 testing and their minor-age children. PURPOSE: This randomized phase III trial is studying standard genetic counseling given together with a decision guide to see how well it works compared with genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.
Conditions
Conditions (2)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hereditary Breast/Ovarian Cancer (brca1, brca2) | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| psychosocial assessment and care | Behavioral | — | UNRESOLVED |
| supportive care | Behavioral | — | UNRESOLVED |
| survey administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (13)
- measure
- Self-reported outcomes at 1-and 6-months
- timeFrame
- 6 months
- measure
- Decision conflict, as assessed by the Decisional Conflict Scale
- timeFrame
- 6 months
- measure
- Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale
- timeFrame
- 6 months
- measure
- Decision quality
- timeFrame
- 6 months
- measure
- Disclosure of genetic testing results by parents
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 8 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Mothers self-identified as primary caregivers to minor-age children (ages 8-21 years-old) * Mothers must be undergoing genetic counseling and have provided a blood sample for analysis for BRCA1/2 mutations * Mothers must have resided in the same home as the child(ren) for the past 6 months and intend to continue to reside with the child(ren) for the next 6 months PATIENT CHARACTERISTICS: * At least 21 years old (mothers) * No serious mental illness (e.g., cognitive and psychotic disorders) or developmental disability that would limit participation or preclude informed consent * Must be able to adequately understand, speak, and read English * Must have ready and consistent access to a telephone PRIOR CONCURRENT THERAPY: * Not specified
References
Publications (0)
Data not yet available