CARE: Cancer Risk Perception and Women of Color | NCT06036875

Studies
CARE: Cancer Risk Perception and Women of Color

NCT06036875

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 10, 2026Actual

Enrollment

324Actual

Phase

Not provided

Conditions

Breast Carcinoma

Interventions

Non-Interventional Study

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-2023-04394	Registry Identifier	CTRP (Clinical Trial Reporting Program)
22-012888	Other Identifier	Mayo Clinic Institutional Review Board

Status Module

Record Verification Date

Mar 2026

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

Mar 25, 2023Actual

Primary Completion Date

Feb 17, 2026Actual

Completion Date

Feb 27, 2026Actual

First Submitted Date

Sep 7, 2023

First Submission Date that Met QC Criteria

Sep 7, 2023

First Posted Date

Sep 14, 2023Actual

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

Mar 6, 2026

Last Update Posted Date

Mar 10, 2026Actual

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 examines patient understanding of current and lifetime risk for breast cancer in women of color from diverse racial and ethnic backgrounds.

Detailed Description

PRIMARY OBJECTIVES:

I. Examine the association between BC risk factors and BC risk perceptions among younger Black and Hispanic women and explore differences in associations by race and ethnicity (Black Hispanic, Black, Hispanic).

II. Explore how younger Black and Hispanic women conceptualize and formulate their risk for BC and to explore the relationship between risk perceptions and risk-reduction strategies.

OUTLINE: This is an observational study.

Patients complete a survey and may participate in an interview on study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

324Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health Services Research		Patients complete a survey and may participate in an interview on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Health Services Research

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perception of risk	Measured using a 0-100% response (percent lifetime risk) and a 5-point verbal scale ranging from 'very low' to 'very high' (ordinal lifetime risk). Participants will also be asked to assess their risk compared to women their age with the response options of 'much lower', 'about the same', and 'much higher' (comparative risk likelihood).	Baseline (at enrollment)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Self-identify as female
Between the ages of 18 and 50
No medical history of breast cancer

Exclusion Criteria:

Unable to understand or comprehend English or Spanish

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Self-identify as female

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Diverse women between 18 and 50 years of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jessica D. Austin, PhD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona		Scottsdale	Arizona	85259	United States
University of Arizona

Label	URL
Mayo Clinic Clinical Trials	View source

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