Breast Cancer Clinical Trial

Factors Influencing Cascade Testing Among Women With Hereditary Gynecological Cancers and Their Relatives

Summary

This trial collects information about factors that affect communication of genetic test results, decision-making, and access to genetic testing in women with hereditary gynecological cancers. Studying individuals who are positive for a genetic mutation and immediate biological family members (including a parent, full-sibling, or child) may help identify cancer genes and other persons at risk.

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Full Description

PRIMARY OBJECTIVES:

I. Identify and explore factors influencing the communication of genetic testing results from probands (patients with confirmed hereditary cancer predisposition syndrome) to their first-degree relatives. (Step 1) II. Identify and explore factors influencing decision making and pursuit of cascade testing among first-degree relatives of probands. (Step 1) III. Estimate the uptake of cascade testing by first-degree relatives of probands at a safety-net hospital and the uptake of cascade testing by first-degree relatives of probands at a comprehensive cancer center. (Step 2) IV. Estimate the frequency of reported factors that influence communication, decision-making, and pursuit of cascade testing among probands and their first-degree family members at a safety-net hospital and at a comprehensive cancer center. (Step 2) V. Explore similarities and differences in cascade genetic testing rates and reported barriers to cascade genetic testing of first-degree relatives at probands from a safety-net hospital and a comprehensive cancer center. (Step 2)

OUTLINE:

STEP I: Patients and first degree relatives participate in semi-structure, in-depth interviews about genetic testing over 45-60 minutes.

STEP II: Patients and first degree relatives complete survey questionnaires over 20 minutes.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

STEP 1 (PROBANDS): Speaks and/or reads English or Spanish
STEP 1 (PROBANDS): Currently receiving diagnostic, treatment, or follow-up care in the outpatient gynecologic oncology and medical oncology clinics at LBJ
STEP 1 (PROBANDS): Has completed genetic counseling, with pedigree available in the medical record (LBJ)
STEP 1 (PROBANDS): Diagnosed with female-breast, ovarian, fallopian tube, primary peritoneal, endometrial cancer on or after January 1, 2014
STEP 1 (PROBANDS): Has a confirmed deleterious or suspected deleterious (pathogenic) variant in a hereditary gynecologic or breast cancer predisposition gene (including BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, BRIP1, PALB2, RAD51C, RAD51D, STK11, DICER1, SMARCA4, ATM, CHEK2, PTEN, TP53, CDH1, BARD1)
STEP 1 (FIRST-DEGREE RELATIVE [FDR]): Speaks and/or reads English or Spanish
STEP 1 (FDR): Is a first-degree relative of proband (son, daughter, full-brother, full-sister, mother, father)
STEP 1 (FDR): Is present with proband at time of recruitment, or can be contacted by telephone via a United States (U.S.) telephone number
STEP 1 (FDR): Is aware of proband's genetic testing result/mutation status, per proband report
STEP 2 (PROBANDS): Speaks or reads English or Spanish
STEP 2 (PROBANDS): Currently receives diagnostic, treatment, or follow-up care for female-breast cancer in the outpatient medical oncology clinics at LBJ; or currently receives diagnostic, treatment, or follow-up care for ovarian, fallopian tube, primary peritoneal or endometrial cancer in the outpatient gynecologic oncology clinic at LBJ or the outpatient gynecologic oncology clinic at The University of Texas MD Anderson Cancer Center (MD Anderson)
STEP 2 (PROBANDS): Diagnosed with eligible cancer on or after January 1, 2014
STEP 2 (PROBANDS): Has completed genetic counseling, with a pedigree available in the medical record (LBJ) or internal clinical and research database (progeny at MD Anderson)
STEP 2 (PROBANDS): Has a confirmed deleterious or suspected deleterious (pathogenic) variant in a hereditary gynecologic or breast cancer predisposition gene (including BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, BRIP1, PALB2, RAD51C, RAD51D, STK11, DICER1, SMARCA4, ATM, CHEK2, PTEN, TP53, CDH1, BARD1)
STEP 2 (FDR): Speak and/or reads English or Spanish
STEP 2 (FDR): First-degree relative of proband (son, daughter, full-brother, full-sister, mother, father)
STEP 2 (FDR): Is present with proband at time of recruitment, or can be contacted by telephone via a U.S. telephone number
STEP 2 (FDR): Is aware of proband's genetic testing result/mutation status, per proband report

Exclusion Criteria:

STEP 1 (PROBANDS): No longer receives outpatient care at LBJ
STEP 1 (PROBANDS): Has a negative genetic testing result, a result identifying only a variant of uncertain significance, or results and pedigree that cannot be confirmed in the electronic medical record
STEP 1 (PROBANDS): Is unwilling or unable to provide informed consent
STEP 1 (FIRST-DEGREE RELATIVE [FDR]): Unwilling or unable to provide informed consent
STEP 2 (PROBANDS): No longer receives outpatient care at LBJ or MD Anderson
STEP 2 (PROBANDS): Has a negative genetic testing result, a result identifying only a variant of uncertain significance, or results and pedigree that cannot be confirmed in the electronic medical record
STEP 2 (PROBANDS): Unwilling or unable to provide informed consent
STEP 2 (PROBANDS): Participated in step 1 interviews
STEP 2 (FDR): Unwilling or unable to provide informed consent
STEP 2 (FDR): Reports no knowledge of proband's genetic testing status
STEP 2 (FDR): Participated in step 1 interviews

Study is for people with:

Breast Cancer

Estimated Enrollment:

320

Study ID:

NCT04257045

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There are 2 Locations for this study

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University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States More Info
Isabel C. Scarinci
Contact
[email protected]
Isabel C. Scarinci
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jose A. Rauh-Hain
Contact
713-794-1759
Jose A. Rauh-Hain
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

320

Study ID:

NCT04257045

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

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