Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

Breast Cancer Clinical Trial

Official title:

Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133703
• Other study ID #: 2010-611
• Secondary ID: R01CA135179-01R0
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Undergo BRCA1/2 genetic counseling and testing at one of four study sites

• Receive positive or uninformative test results

• English speaking

Exclusion Criteria:

• Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment

• Previous bilateral mastectomy

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Enhanced Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
• Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options.
• Enhanced Print DA
BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
• Print DA
BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
• Inconclusive Results DA
Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center/Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge	Knowledge of risk management options.	1-month post randomization
Primary	Decision Conflict	Decisional Conflict Scale	1-month post-randomization
Primary	Decision Satisfaction	Satisfaction with Decision Scale	12-months post-randomization
Primary	Psychological Distress		1-month post randomization
Primary	Health Related Quality of Life	SF-12	12-months post randomization
Primary	Utilization of breast and ovarian cancer risk management options	We will assess uptake of the following risk management strategies: Risk reducing surgery (mastectomy and oophorectomy); Chemoprevention; Breast and ovarian cancer screening	12-months post-randomization
Secondary	Knowledge	Knowledge of risk management options	3-months post randomization
Secondary	Psychological Distress		3-months post-randomization
Secondary	Decisional Conflict	Decisional Conflict Scale	3-months post-randomization