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CompletedNCT05158452Updated Nov 9, 2022

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

An observational study in Breast Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 35 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by Ohio State University Comprehensive Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
8
Ages
35 Years to 64 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Carcinoma

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 8 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women at elevated risk for breast cancer

Eligibility criteria

Inclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
8 participants (actual)

Groups and cohorts

  • Observational (focus group)

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

    Procedure: Discussion

Interventions

  • ProcedureDiscussion

    Attend a focus group

    Also known as: Discuss

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What researchers measure

Primary outcomes

  1. Development of Genetic Counseling Patient Preference (GCPP) intervention

    Time frame: Up to 2 years

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Study locations

1 site
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
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References and documents

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05158452
Lead sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Kevin Sweet (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Dec 15, 2021
Start date
Dec 9, 2020
Primary completion
Oct 30, 2022
Completion
Oct 30, 2022
Last update
Nov 9, 2022

Study contacts

Kevin Sweet, MS, LGC
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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