Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

October 12, 2022 updated by: Georgetown University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

369

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center/Lombardi Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mutation Carrier: Enhanced Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
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.
Experimental: Mutation Carrier: Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.
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.
Active Comparator: Mutation Carrier: Enhanced Print DA
BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.
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.
Active Comparator: Mutation Carrier: Print DA
BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.
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.
Experimental: Inconclusive Results: DA
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
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.
No Intervention: Inconclusive Results: Usual care
Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: 1-month post randomization
Knowledge of risk management options.
1-month post randomization
Decision Conflict
Time Frame: 1-month post-randomization
Decisional Conflict Scale
1-month post-randomization
Decision Satisfaction
Time Frame: 12-months post-randomization
Satisfaction with Decision Scale
12-months post-randomization
Psychological Distress
Time Frame: 1-month post randomization
1-month post randomization
Health Related Quality of Life
Time Frame: 12-months post randomization
SF-12
12-months post randomization
Utilization of breast and ovarian cancer risk management options
Time Frame: 12-months post-randomization

We will assess uptake of the following risk management strategies:

  1. Risk reducing surgery (mastectomy and oophorectomy)
  2. Chemoprevention
  3. Breast and ovarian cancer screening
12-months post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: 3-months post randomization
Knowledge of risk management options
3-months post randomization
Psychological Distress
Time Frame: 3-months post-randomization
3-months post-randomization
Decisional Conflict
Time Frame: 3-months post-randomization
Decisional Conflict Scale
3-months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Marc D Schwartz, PhD, Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-611
  • R01CA135179-01 (U.S. NIH Grant/Contract)
  • R01HG005055 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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