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NCT05158452 Clinical Trial

Development of a Genetic Counseling Patient Preference Intervention for Women at Elevated Risk for Breast Cancer

Breast Carcinoma Clinical Trial

Official title:
Development of a Genetic Counseling Patient Preference Intervention for Women at Elevated Risk for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05158452
Other study ID # OSU-20380
Secondary ID NCI-2021-01883R0
Status Completed
Phase
First received
Last updated
Start date December 9, 2020
Est. completion date October 30, 2022

Study information
Verified date November 2022
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study develops a genetic counseling patient preference intervention for women at elevated risk for breast cancer. This study aims to develop an intervention that may deliver educational videos about breast cancer, heredity, multigene tests results and polygenic risk score, provide multigene and polygenic test results, obtain information about patients' questions/ concerns about test results to use in post-genetic test counseling, and determine patient preference (e.g. telephone) for receipt of post-genetic test counseling.

Description:

PRIMARY OBJECTIVE: I. Develop the Genetic Counseling Patient Preference (GCPP) intervention in collaboration with community members. OUTLINE: Participants attend a focus group over 90-120 minutes providing feedback on GCPP intervention.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 64 Years
Eligibility Inclusion Criteria: - Female - Ages 35-64 - Known elevated risk for breast cancer - The ability to speak and read English - Provide written consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Discussion
Attend a focus group

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (2)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development of Genetic Counseling Patient Preference (GCPP) intervention Up to 2 years
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