Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

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.

Conditions

• Breast Cancer
• Ovarian Cancer

Interventions

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

Print DA

BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

• Georgetown University

  lead OTHER

Principal Investigators

• Marc D Schwartz, PhD · Georgetown University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2022-07-01

Completion

2022-07-01

Countries

• United States

Study Locations