Clinical trial · Interventional
Testing a Culturally Adapted Telephone Genetic Counseling Intervention
Testing a Culturally Adapted Telephone Genetic Counseling Intervention to Enhance Genetic Risk Assessment in Underserved Latinas at Risk of Hereditary Breast and Ovarian Cancer
NCT03959267CI-TRIAL-00053636completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Participating in genetic cancer risk assessments (GCRA) for hereditary breast and ovarian cancer (HBOC) can inform treatment and risk management decisions and improve breast cancer outcomes. However, Latina women underuse GCRA services, which may increase breast cancer disparities. This study will adapt and test the impact of a Culturally Adapted Telephone Genetic Counseling Intervention to enhance the use and quality of genetic counseling services for underserved Latina women at-risk of hereditary breast and ovarian cancer
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 Cancer | Hereditary Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telephone Genetic Counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Participants will continue with their usual medical care. Usual care may vary at different sites. Based on the investigator's preliminary data usual care can result in not GCRA referral, referral directly to testing, or referral to genetic counseling with an interpreter. The investigators will document usual care for participants from the sites randomized to usual care.
- type
- OTHER
- label
- Telephone Genetic Counseling
- description
- Participants will receive telephone genetic counseling with the culturally adapted protocol and booklet
- interventionNames
- Behavioral: Telephone Genetic Counseling
Primary outcomes (1)
- measure
- Number of participants that receive genetic cancer risk assessment (GCRA)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Self-identify as Latina/Hispanic * Be 21 years old or older * Be at risk of hereditary breast and ovarian cancer because of personal and/or family medical history according to NCCN guidelines * Be diagnosed with breast cancer, and have completed active treatment (i.e., chemotherapy, radiation, surgeries) * Be able to provide the name and contact information of a primary healthcare provider, whom they see at least once a year * Speak and read Spanish. Exclusion Criteria: * Do not identify as Latina/Hispanic. * Younger than 21 years old. * Do not meet current national guidelines to be considered at risk for hereditary breast and ovarian cancer. * Has been diagnosed with ovarian cancer or stage IV breast cancer. * Has not completed active treatment (e.g., surgery, chemotherapy, radiation). * Is not able to provide the name and contact information of the primary healthcare provider. This must be someone whom they have seen at least once during the past 12 months. * Cannot provide consent to participate. * Has received genetic counseling by a genetics professional (e.g., genetic counselor or genetics nurse). * Has participated in a previous phase of this study. * Cannot provide a copy of their genetic test results.
References
Publications (27)
- BACKGROUNDChen S, Parmigiani G. Meta-analysis of BRCA1 and BRCA2 penetrance. J Clin Oncol. 2007 Apr 10;25(11):1329-33. doi: 10.1200/JCO.2006.09.1066. PMID 17416853
- BACKGROUNDValachis A, Nearchou AD, Lind P. Surgical management of breast cancer in BRCA-mutation carriers: a systematic review and meta-analysis. Breast Cancer Res Treat. 2014 Apr;144(3):443-55. doi: 10.1007/s10549-014-2890-1. Epub 2014 Feb 25. PMID 24567198
- BACKGROUNDKauff ND, Satagopan JM, Robson ME, Scheuer L, Hensley M, Hudis CA, Ellis NA, Boyd J, Borgen PI, Barakat RR, Norton L, Castiel M, Nafa K, Offit K. Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med. 2002 May 23;346(21):1609-15. doi: 10.1056/NEJMoa020119. Epub 2002 May 20. PMID 12023992
- BACKGROUNDWeitzel JN, Clague J, Martir-Negron A, Ogaz R, Herzog J, Ricker C, Jungbluth C, Cina C, Duncan P, Unzeitig G, Saldivar JS, Beattie M, Feldman N, Sand S, Port D, Barragan DI, John EM, Neuhausen SL, Larson GP. Prevalence and type of BRCA mutations in Hispanics undergoing genetic cancer risk assessment in the southwestern United States: a report from the Clinical Cancer Genetics Community Research Network. J Clin Oncol. 2013 Jan 10;31(2):210-6. doi: 10.1200/JCO.2011.41.0027. Epub 2012 Dec 10. PMID 23233716
- BACKGROUNDDean M, Boland J, Yeager M, Im KM, Garland L, Rodriguez-Herrera M, Perez M, Mitchell J, Roberson D, Jones K, Lee HJ, Eggebeen R, Sawitzke J, Bass S, Zhang X, Robles V, Hollis C, Barajas C, Rath E, Arentz C, Figueroa JA, Nguyen DD, Nahleh Z. Addressing health disparities in Hispanic breast cancer: accurate and inexpensive sequencing of BRCA1 and BRCA2. Gigascience. 2015 Nov 4;4:50. doi: 10.1186/s13742-015-0088-z. eCollection 2015. PMID 26543556
- BACKGROUNDGlenn BA, Chawla N, Bastani R. Barriers to genetic testing for breast cancer risk among ethnic minority women: an exploratory study. Ethn Dis. 2012 Summer;22(3):267-73.