Development of a Genetic Counseling Patient Preference In... | NCT05158452

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

NCT05158452

Sponsor

Ohio State University Comprehensive Cancer Center

Status

Completed

Last Update Posted

Nov 9, 2022Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Breast Carcinoma

Interventions

Discussion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-01883	Registry Identifier	CTRP (Clinical Trial Reporting Program)
R01CA248739	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2020Actual

Primary Completion Date

Oct 30, 2022Actual

Completion Date

Oct 30, 2022Actual

First Submitted Date

Dec 3, 2021

First Submission Date that Met QC Criteria

Dec 3, 2021

First Posted Date

Dec 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2022

Last Update Posted Date

Nov 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kevin Sweet, Principal Investigator, Ohio State University Comprehensive Cancer CenterPrincipal Investigator

Lead Sponsor

Ohio State University Comprehensive Cancer CenterOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (focus group)		Participants attend a focus group over 90-120 minutes providing feedback on GCPP intervention.	Procedure: Discussion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Discussion	Procedure	Attend a focus group	Observational (focus group)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of Genetic Counseling Patient Preference (GCPP) intervention		Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Women at elevated risk for breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Sweet, MS, LGC	Ohio State University Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ohio State University Comprehensive Cancer Center		Columbus	Ohio	43210	United States

Label	URL
The Jamesline	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided