NCT02133703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 14, 2022

Status Verified

September 1, 2022

Enrollment Period

6.8 years

First QC Date

April 9, 2014

Last Update Submit

October 12, 2022

Conditions

Breast CancerOvarian Cancer

Keywords

Genetic counselinggenetic testingBRCA1BRCA2Hereditary breast cancerHereditary ovarian cancer

Outcome Measures

Primary Outcomes (6)

  • Knowledge

    Knowledge of risk management options.

    1-month post randomization

  • Decision Conflict

    Decisional Conflict Scale

    1-month post-randomization

  • Decision Satisfaction

    Satisfaction with Decision Scale

    12-months post-randomization

  • Psychological Distress

    1-month post randomization

  • Health Related Quality of Life

    SF-12

    12-months post randomization

  • Utilization of breast and ovarian cancer risk management options

    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 Outcomes (3)

  • Knowledge

    3-months post randomization

  • Psychological Distress

    3-months post-randomization

  • Decisional Conflict

    3-months post-randomization

Study Arms (6)

Mutation Carrier: Enhanced Internet DA

EXPERIMENTAL

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

Behavioral: Enhanced Internet DA

Mutation Carrier: Internet DA

EXPERIMENTAL

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

Behavioral: Internet DA

Mutation Carrier: Enhanced Print DA

ACTIVE COMPARATOR

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

Mutation Carrier: Print DA

ACTIVE COMPARATOR

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

Behavioral: Print DA

Inconclusive Results: DA

EXPERIMENTAL

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

Inconclusive Results: Usual care

NO INTERVENTION

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

Interventions

Enhanced Internet DABEHAVIORAL

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.

Mutation Carrier: Enhanced Internet DA
Internet DABEHAVIORAL

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.

Mutation Carrier: Internet DA
Enhanced Print DABEHAVIORAL

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.

Mutation Carrier: Enhanced Print DA
Print DABEHAVIORAL

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

Mutation Carrier: Print DA
Inconclusive Results DABEHAVIORAL

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.

Inconclusive Results: DA

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergo BRCA1/2 genetic counseling and testing at one of four study sites
  • Receive positive or uninformative test results
  • English speaking

You may not qualify if:

  • Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
  • Previous bilateral mastectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center/Lombardi Comprehensive Cancer Center

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

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsBreast Cancer, Familial

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Marc D Schwartz, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2014

First Posted

May 8, 2014

Study Start

October 1, 2015

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

October 14, 2022

Record last verified: 2022-09

Locations

US(1)