Clinical trial · Interventional
Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
Telephone-Based Genetic Counseling; An Equivalence Trial
- 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: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation. PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telephone Genetic Counseling | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Telephone Genetic Counseling
- description
- Participants randomized to this arm will receive all genetic counseling via telephone.
- interventionNames
- Behavioral: Telephone Genetic Counseling
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Participants randomized to usual care will receive standard in-person genetic counseling.
- interventionNames
- Behavioral: Usual Care
Primary outcomes (5)
- measure
- Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 85 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following: * First-degree relative of affected family member with a 50% chance of inheriting a BRCA1/BRCA2 mutation * Second-degree relative with BRCA1/BRCA2 mutation with 25% risk of inheritance (parent deceased) * Obligate gene carrier or affected woman * Must live within 100 miles of the Lombardi Comprehensive Cancer Center * No more than 4 weeks since breast or ovarian cancer diagnosis * No metastatic or inflammatory breast cancer or ovarian cancer * No stage III breast or ovarian cancer while undergoing concurrent chemotherapy PATIENT CHARACTERISTICS: * No psychiatric illness or cognitive disorder that would preclude informed consent PRIOR CONCURRENT THERAPY: * No prior genetic counseling or testing for BRCA1 and/or BRCA2
References
Publications (2)
- DERIVEDPeshkin BN, Kelly S, Nusbaum RH, Similuk M, DeMarco TA, Hooker GW, Valdimarsdottir HB, Forman AD, Joines JR, Davis C, McCormick SR, McKinnon W, Graves KD, Isaacs C, Garber J, Wood M, Jandorf L, Schwartz MD. Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counseling. J Genet Couns. 2016 Jun;25(3):472-82. doi: 10.1007/s10897-015-9897-6. Epub 2015 Oct 12. PMID 26455498
- DERIVEDSchwartz MD, Valdimarsdottir HB, Peshkin BN, Mandelblatt J, Nusbaum R, Huang AT, Chang Y, Graves K, Isaacs C, Wood M, McKinnon W, Garber J, McCormick S, Kinney AY, Luta G, Kelleher S, Leventhal KG, Vegella P, Tong A, King L. Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer. J Clin Oncol. 2014 Mar 1;32(7):618-26. doi: 10.1200/JCO.2013.51.3226. Epub 2014 Jan 21. PMID 24449235