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Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

Primary Purpose

Breast Cancer, Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Internet DA
Internet DA
Enhanced Print DA
Print DA
Inconclusive Results DA
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Genetic counseling, genetic testing, BRCA1, BRCA2, Hereditary breast cancer, Hereditary ovarian cancer

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Georgetown University Medical Center/Lombardi Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

No Intervention

Arm Label

Mutation Carrier: Enhanced Internet DA

Mutation Carrier: Internet DA

Mutation Carrier: Enhanced Print DA

Mutation Carrier: Print DA

Inconclusive Results: DA

Inconclusive Results: Usual care

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Knowledge
Knowledge of risk management options.
Decision Conflict
Decisional Conflict Scale
Decision Satisfaction
Satisfaction with Decision Scale
Psychological Distress
Health Related Quality of Life
SF-12
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

Secondary Outcome Measures

Knowledge
Knowledge of risk management options
Psychological Distress
Decisional Conflict
Decisional Conflict Scale

Full Information

First Posted
April 9, 2014
Last Updated
October 12, 2022
Sponsor
Georgetown University
Collaborators
National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)
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1. Study Identification

Unique Protocol Identification Number
NCT02133703
Brief Title
Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
Official Title
Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ovarian Cancer
Keywords
Genetic counseling, genetic testing, BRCA1, BRCA2, Hereditary breast cancer, Hereditary ovarian cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mutation Carrier: Enhanced Internet DA
Arm Type
Experimental
Arm Description
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
Arm Title
Mutation Carrier: Internet DA
Arm Type
Experimental
Arm Description
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.
Arm Title
Mutation Carrier: Enhanced Print DA
Arm Type
Active Comparator
Arm Description
BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.
Arm Title
Mutation Carrier: Print DA
Arm Type
Active Comparator
Arm Description
BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.
Arm Title
Inconclusive Results: DA
Arm Type
Experimental
Arm 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
Arm Title
Inconclusive Results: Usual care
Arm Type
No Intervention
Arm Description
Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Internet DA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet DA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Print DA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Print DA
Intervention Description
BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
Intervention Type
Behavioral
Intervention Name(s)
Inconclusive Results DA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge
Description
Knowledge of risk management options.
Time Frame
1-month post randomization
Title
Decision Conflict
Description
Decisional Conflict Scale
Time Frame
1-month post-randomization
Title
Decision Satisfaction
Description
Satisfaction with Decision Scale
Time Frame
12-months post-randomization
Title
Psychological Distress
Time Frame
1-month post randomization
Title
Health Related Quality of Life
Description
SF-12
Time Frame
12-months post randomization
Title
Utilization of breast and ovarian cancer risk management options
Description
We will assess uptake of the following risk management strategies: Risk reducing surgery (mastectomy and oophorectomy) Chemoprevention Breast and ovarian cancer screening
Time Frame
12-months post-randomization
Secondary Outcome Measure Information:
Title
Knowledge
Description
Knowledge of risk management options
Time Frame
3-months post randomization
Title
Psychological Distress
Time Frame
3-months post-randomization
Title
Decisional Conflict
Description
Decisional Conflict Scale
Time Frame
3-months post-randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc D Schwartz, PhD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

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Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

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