Testing a Culturally Adapted Telephone Genetic Counseling Intervention

NCT03959267 | Completed

• 1 other identifier: KL2TR001432
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

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

Breast Cancer; Hereditary Breast Cancer

Keywords

Latinas; Survivors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in knowledge

  Change from baseline to three months after baseline

• Change in decisional conflict

  Change from baseline to three months after baseline

• Distress

  At baseline

• Decision Satisfaction

  Three months after baseline

• Satisfaction with counseling

  Three months after baseline

Other Outcomes (3)

• Communication

  Three months after baseline

• Communication

  Three months after baseline

• Acceptability

  Thee months after baseline

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Telephone Genetic Counseling

OTHER

Participants will receive telephone genetic counseling with the culturally adapted protocol and booklet

Behavioral: Telephone Genetic Counseling

Interventions

Telephone Genetic Counseling BEHAVIORAL

A genetic counselor fluent in Spanish (see letter of support) will conduct the TGC. The TGC intervention consists of two sessions. Prior to the sessions the investigators will mail participants the education materials with information to be reviewed prior to the genetic counseling session and a set of visual aids that the counselor will refer to during the session to facilitate the understanding of the information conveyed in the session.

Telephone Genetic Counseling

Eligibility Criteria

• Age: 21 Years - 90 Years
• Gender Eligibility Details: Based on the self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead
• Hackensack Meridian Health: collaborator

Study Sites (4)

Capital Breast Care Center

Washington D.C., District of Columbia, 20003, United States

Location

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

Nueva Vida

Alexandria, Virginia, 22314, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (27)

• Chen 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 BACKGROUND

• 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.

  PMID: 24567198 BACKGROUND

• 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. doi: 10.1056/NEJMoa020119. Epub 2002 May 20.

  PMID: 12023992 BACKGROUND

• 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.

  PMID: 23233716 BACKGROUND

• 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.

  PMID: 26543556 BACKGROUND

• 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.

  PMID: 22870568 BACKGROUND

• 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.

  PMID: 22987526 BACKGROUND

• 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.

  PMID: 25120034 BACKGROUND

• 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.

  PMID: 20151317 BACKGROUND

• 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. doi: 10.1016/s0738-3991(02)00219-7.

  PMID: 14630378 BACKGROUND

• 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. doi: 10.1001/jama.293.14.1729.

  PMID: 15827311 BACKGROUND

• Hall MJ, Olopade OI. Disparities in genetic testing: thinking outside the BRCA box. J Clin Oncol. 2006 May 10;24(14):2197-203. doi: 10.1200/JCO.2006.05.5889.

  PMID: 16682739 BACKGROUND

• 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.

  PMID: 24449235 BACKGROUND

• 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):dju328. doi: 10.1093/jnci/dju328. Print 2014 Dec.

  PMID: 25376862 BACKGROUND

• 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.

  PMID: 25148879 BACKGROUND

• 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. doi: 10.1111/j.1525-1497.2006.00451.x.

  PMID: 16808747 BACKGROUND

• 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. doi: 10.1016/s0277-9536(02)00214-9.

  PMID: 12650730 BACKGROUND

• 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. doi: 10.1002/14651858.CD001431.

  PMID: 11686990 BACKGROUND

• 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. doi: 10.1016/s0738-3991(02)00012-5.

  PMID: 11932123 BACKGROUND

• 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.

  PMID: 20061960 BACKGROUND

• 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. doi: 10.1016/j.pec.2004.02.007.

  PMID: 15653247 BACKGROUND

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

  PMID: 7898294 BACKGROUND

• Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.

  PMID: 472086 BACKGROUND

• 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. doi: 10.1177/0272989X9601600114.

  PMID: 8717600 BACKGROUND

• 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. doi: 10.1023/b:jogc.0000035523.96133.bc.

  PMID: 19736695 BACKGROUND

• 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. doi: 10.1002/ajmg.a.30317.

  PMID: 15389697 BACKGROUND

• Gomez-Trillos S, Graves KD, Fiallos K, Schwartz MD, Peshkin BN, Hamilton H, Sheppard VB, Vadaparampil ST, Campos C, Cupertino AP, Alzamora MC, Lynce F, Hurtado-de-Mendoza A. Cultural adaptations to a telephone genetic counseling protocol and booklet for Latina breast cancer survivors at risk for hereditary breast and ovarian cancer. Transl Behav Med. 2023 May 13;13(5):297-308. doi: 10.1093/tbm/ibac106.

  PMID: 36694918 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer, Familial

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alejandra Hurtado de Mendoza, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators will conduct a two-arm Randomized Controlled Trial (RCT) comparing Telephone Genetic Counseling in Spanish vs. Usual care.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 22, 2019
• Study Start: July 7, 2017
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

US (4)