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

NCT ID: NCT05158452

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-09

Study Completion Date

2022-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (focus group)

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

Discussion

Intervention Type PROCEDURE

Attend a focus group

Interventions

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Discussion

Attend a focus group

Intervention Type PROCEDURE

Other Intervention Names

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Discuss

Eligibility Criteria

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Inclusion Criteria

* Female
* Ages 35-64
* Known elevated risk for breast cancer
* The ability to speak and read English
* Provide written consent
Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Kevin Sweet

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Sweet, MS, LGC

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2021-01883

Identifier Type: REGISTRY

Identifier Source: secondary_id

R01CA248739

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-20380

Identifier Type: -

Identifier Source: org_study_id

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