Breast Cancer Clinical Trial
Official title:
Testing a Culturally Adapted Telephone Genetic Counseling Intervention to Enhance Genetic Risk Assessment in Underserved Latinas at Risk of Hereditary Breast and Ovarian Cancer
Verified date | August 2021 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 37 |
Est. completion date | January 30, 2021 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Nueva Vida | Alexandria | Virginia |
United States | Hackensack Meridian Health | Hackensack | New Jersey |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Capital Breast Care Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University | Hackensack Meridian Health |
United States,
Aranguri C, Davidson B, Ramirez R. Patterns of communication through interpreters: a detailed sociolinguistic analysis. J Gen Intern Med. 2006 Jun;21(6):623-9. — View Citation
Armstrong K, Micco E, Carney A, Stopfer J, Putt M. Racial differences in the use of BRCA1/2 testing among women with a family history of breast or ovarian cancer. JAMA. 2005 Apr 13;293(14):1729-36. — View Citation
Browner CH, Preloran HM, Casado MC, Bass HN, Walker AP. Genetic counseling gone awry: miscommunication between prenatal genetic service providers and Mexican-origin clients. Soc Sci Med. 2003 May;56(9):1933-46. — View Citation
Chen S, Parmigiani G. Meta-analysis of BRCA1 and BRCA2 penetrance. J Clin Oncol. 2007 Apr 10;25(11):1329-33. — View Citation
Dean 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. — View Citation
DeMarco TA, Peshkin BN, Mars BD, Tercyak KP. Patient satisfaction with cancer genetic counseling: a psychometric analysis of the Genetic Counseling Satisfaction Scale. J Genet Couns. 2004 Aug;13(4):293-304. — View Citation
Erblich J, Brown K, Kim Y, Valdimarsdottir HB, Livingston BE, Bovbjerg DH. Development and validation of a Breast Cancer Genetic Counseling Knowledge Questionnaire. Patient Educ Couns. 2005 Feb;56(2):182-91. — View Citation
Glenn 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. — View Citation
Hall MJ, Olopade OI. Disparities in genetic testing: thinking outside the BRCA box. J Clin Oncol. 2006 May 10;24(14):2197-203. Review. — View Citation
Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. — View Citation
Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. — View Citation
Joseph G, Guerra C. To worry or not to worry: breast cancer genetic counseling communication with low-income Latina immigrants. J Community Genet. 2015 Jan;6(1):63-76. doi: 10.1007/s12687-014-0202-4. Epub 2014 Aug 23. — View Citation
Kauff 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. Epub 2002 May 20. — View Citation
Kinney AY, Butler KM, Schwartz MD, Mandelblatt JS, Boucher KM, Pappas LM, Gammon A, Kohlmann W, Edwards SL, Stroup AM, Buys SS, Flores KG, Campo RA. Expanding access to BRCA1/2 genetic counseling with telephone delivery: a cluster randomized trial. J Natl Cancer Inst. 2014 Nov 5;106(12). pii: dju328. doi: 10.1093/jnci/dju328. Print 2014 Dec. — View Citation
Kinney AY, Gammon A, Coxworth J, Simonsen SE, Arce-Laretta M. Exploring attitudes, beliefs, and communication preferences of Latino community members regarding BRCA1/2 mutation testing and preventive strategies. Genet Med. 2010 Feb;12(2):105-15. doi: 10.1097/GIM.0b013e3181c9af2d. — View Citation
O'Connor AM, Stacey D, Rovner D, Holmes-Rovner M, Tetroe J, Llewellyn-Thomas H, Entwistle V, Rostom A, Fiset V, Barry M, Jones J. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2001;(3):CD001431. Review. Update in: Cochrane Database Syst Rev. 2003;(2):CD001431. — View Citation
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. — View Citation
Roter D, Larson S. The Roter interaction analysis system (RIAS): utility and flexibility for analysis of medical interactions. Patient Educ Couns. 2002 Apr;46(4):243-51. — View Citation
Schwartz 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. — View Citation
Sussner KM, Edwards T, Villagra C, Rodriguez MC, Thompson HS, Jandorf L, Valdimarsdottir HB. BRCA genetic counseling among at-risk Latinas in New York City: new beliefs shape new generation. J Genet Couns. 2015 Feb;24(1):134-48. doi: 10.1007/s10897-014-9746-z. Epub 2014 Aug 15. — View Citation
Sussner KM, Jandorf L, Thompson HS, Valdimarsdottir HB. Barriers and facilitators to BRCA genetic counseling among at-risk Latinas in New York City. Psychooncology. 2013 Jul;22(7):1594-604. doi: 10.1002/pon.3187. Epub 2012 Sep 16. — View Citation
Sussner KM, Jandorf L, Thompson HS, Valdimarsdottir HB. Interest and beliefs about BRCA genetic counseling among at-risk Latinas in New York City. J Genet Couns. 2010 Jun;19(3):255-68. doi: 10.1007/s10897-010-9282-4. Epub 2010 Feb 12. — View Citation
Tercyak KP, Demarco TA, Mars BD, Peshkin BN. Women's satisfaction with genetic counseling for hereditary breast-ovarian cancer: psychological aspects. Am J Med Genet A. 2004 Nov 15;131(1):36-41. — View Citation
Thompson HS, Valdimarsdottir HB, Jandorf L, Redd W. Perceived disadvantages and concerns about abuses of genetic testing for cancer risk: differences across African American, Latina and Caucasian women. Patient Educ Couns. 2003 Nov;51(3):217-27. — View Citation
Valachis 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. Review. — View Citation
Weitzel 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. Erratum in: J Clin Oncol. 2013 May 1;31(13):1702. — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Communication | Communication outcomes will be qualitatively measured using discourse analysis (e.g., "Number of patient-initiated questions" will be coded following guidelines). | Three months after baseline | |
Other | Communication | Communication outcomes will be quantitatively measured following RIAS medical interaction coding guidelines (e.g., patient centeredness). | Three months after baseline | |
Other | Acceptability | Using a 12-item scale, the RA will assess whether participants perceived the genetic counseling session as acceptable or not based on answers from 1 - 10 and "Strongly disagree" to "Strongly agree" | Thee months after baseline | |
Primary | Number of participants that receive genetic cancer risk assessment (GCRA) | The RA will conduct a follow-up call to inquire whether participants randomized to Usual Care completed a GCRA appointment and to gather information about the place where the appointment was held and name of the genetic counselor | Three months after baseline | |
Secondary | Change in knowledge | The investigators will measure knowledge with the 13-item Breast Cancer Genetic Knowledge Scale by Erblich et al., 2005 answered in a True/False/Do not know format. Answers are recoded to correct or incorrect. The number of correct responses are added to create a score ranging from 0-13. Higher scores mean higher breast cancer genetics knowledge. | Change from baseline to three months after baseline | |
Secondary | Change in decisional conflict | The investigators will measure decisional conflict with the 16-item Decisional-Conflict Scale by O'Connor AM, 1995. The scale is rated on a 1-5 scale. Answers are aggregated to yield a score from 16-80. The higher the final score, the least decisional conflict. | Change from baseline to three months after baseline | |
Secondary | Distress | The investigators will measure distress using the Patient Reported Outcomes Measurement Information System (PROMIS) short anxiety scale by Pilkonis, P.A., Choi, S.W., Reise, S.P., Stover, A.M., Riley, W.T., Cella, D., on behalf of the PROMIS Cooperative Group. (2011). The scale is 1 - 6 scale, in which higher scores mean higher distress. | At baseline | |
Secondary | Decision Satisfaction | The investigators will measure satisfaction with healthcare decisions using the 5 item Satisfaction with healthcare decisions scale by Holmes-Rovner M, Kroll J, Schmitt N, et al., 1996. The scale answers go from 1- 5. The higher scores represent higher satisfaction with healthcare decisions. | Three months after baseline | |
Secondary | Satisfaction with counseling | The investigators use a scale developed by their team, which have been used in prior published work (see DeMarco TA, Peshkin BN, Mars BD, Tercyak KP., 2004 and Tercyak KP, Demarco TA, Mars BD, Peshkin BN., 2004). This 5-item scale is answered from 1-5, with higher scores signifying higher satisfaction with counseling. | Three months after baseline | |
Secondary | Number of participants that receive genetic testing | The RA will conduct a follow-up call to inquire whether participants pursued genetic testing or not. | Three months after baseline |
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