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

NCT05158452 | Completed

• 3 other identifiers: OSU-20380NCI-2021-01883R01CA248739
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Development of Genetic Counseling Patient Preference (GCPP) intervention

  Up to 2 years

Study Arms (1)

Observational (focus group)

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

Procedure: Discussion

Interventions

Discussion PROCEDURE

Attend a focus group

Also known as: Discuss

Observational (focus group)

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women at elevated risk for breast cancer

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kevin Sweet, MS, LGC

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 15, 2021
• Study Start: December 9, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)