Development of a Genetic Counseling Patient Preference Intervention for Women at Elevated Risk for Breast Cancer
November 8, 2022 updated by: Kevin Sweet, Ohio State University Comprehensive Cancer Center
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Actual)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women at elevated risk for breast cancer
Description
Inclusion Criteria:
- Female
- Ages 35-64
- Known elevated risk for breast cancer
- The ability to speak and read English
- Provide written consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (focus group)
Participants attend a focus group over 90-120 minutes providing feedback on GCPP intervention.
|
Attend a focus group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Development of Genetic Counseling Patient Preference (GCPP) intervention
Time Frame: Up to 2 years
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2020
Primary Completion (Actual)
October 30, 2022
Study Completion (Actual)
October 30, 2022
Study Registration Dates
First Submitted
December 3, 2021
First Submitted That Met QC Criteria
December 3, 2021
First Posted (Actual)
December 15, 2021
Study Record Updates
Last Update Posted (Actual)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-20380
- NCI-2021-01883 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA248739 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.