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Completed

NCT Number: NCT02133703

Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Cancer, Familial Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

21 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University Medical Center/Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Internet DA

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. Knowledge

    Time frame: 1-month post randomization

    Knowledge of risk management options.

  2. Decision Conflict

    Time frame: 1-month post-randomization

    Decisional Conflict Scale

  3. Decision Satisfaction

    Time frame: 12-months post-randomization

    Satisfaction with Decision Scale

  4. Psychological Distress

    Time frame: 1-month post randomization

  5. Health Related Quality of Life

    Time frame: 12-months post randomization

    SF-12

  6. 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:

    • Risk reducing surgery (mastectomy and oophorectomy)
    • Chemoprevention
    • Breast and ovarian cancer screening

Secondary outcomes

  1. Knowledge

    Time frame: 3-months post randomization

    Knowledge of risk management options

  2. Psychological Distress

    Time frame: 3-months post-randomization

  3. Decisional Conflict

    Time frame: 3-months post-randomization

    Decisional Conflict Scale

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
May 8, 2014
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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