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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05158452
Collaborator
National Cancer Institute (NCI) (NIH)
16
Enrollment
1
Location
48.7
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Discussion

Detailed Description

PRIMARY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
16 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Development of a Genetic Counseling Patient Preference Intervention for Women at Elevated Risk for Breast Cancer
Actual Study Start Date :
Dec 9, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Observational (focus group)

Participants attend a focus group over 90-120 minutes providing feedback on GCPP intervention.

Procedure: Discussion
Attend a focus group
Other Names:
  • Discuss

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Development of Genetic Counseling Patient Preference (GCPP) intervention [Up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 64 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female

    • Ages 35-64

    • Known elevated risk for breast cancer

    • The ability to speak and read English

    • Provide written consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Kevin Sweet, MS, LGC, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kevin Sweet, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05158452
    Other Study ID Numbers:
    • OSU-20380
    • NCI-2021-01883
    • R01CA248739
    First Posted:
    Dec 15, 2021
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Apr 25, 2022