Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

Georgetown University

Status: Completed

Conditions: Breast Cancer; Ovarian Cancer

Treatments: Behavioral: Enhanced Internet DA; Behavioral: Internet DA; Behavioral: Inconclusive Results DA; Behavioral: Enhanced Print DA; Behavioral: Print DA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02133703

R01CA135179-01 (U.S. NIH Grant/Contract)

2010-611

R01HG005055 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 369 patients

Sex: Female

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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369 participants in 6 patient groups

Mutation Carrier: Enhanced Internet DA

Experimental group

Description:

BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.

Treatment:

Behavioral: Enhanced Internet DA

Mutation Carrier: Internet DA

Experimental group

Description:

BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.

Treatment:

Behavioral: Internet DA

Mutation Carrier: Enhanced Print DA

Active Comparator group

Description:

BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.

Treatment:

Behavioral: Enhanced Print DA

Mutation Carrier: Print DA

Active Comparator group

Description:

BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.

Treatment:

Behavioral: Print DA

Inconclusive Results: DA

Experimental group

Description:

Participants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making

Treatment:

Behavioral: Inconclusive Results DA

Inconclusive Results: Usual care

No Intervention group

Description:

Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention