CARE: Cancer Risk Perception and Women of Color

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06036875
• Collaborator: (none)
• Enrollment: 340
• Locations: 2
• Anticipated Duration (Months): 60
• Patients Per Site: 170
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma	Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

1. 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).

2. 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 340 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: CARE: Cancer Risk Perception and Women of Color
• Actual Study Start Date: Feb 23, 2023
• Anticipated Primary Completion Date: Feb 23, 2028
• Anticipated Study Completion Date: Feb 23, 2028

Arms and Interventions

Arm	Intervention/Treatment
Health Services Research Patients complete a survey and may participate in an interview on study.	Other: Non-Interventional Study; Non-interventional study

Outcome Measures

Primary Outcome Measures

1. Perception of risk [Baseline (at enrollment)]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Self-identify as female

• Between the ages of 25 and 50

• No medical history of breast cancer

• Reside in Arizona or Florida

Exclusion Criteria:

• Unable to understand or comprehend English or Spanish

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Jessica D Austin, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT06036875
• Other Study ID Numbers: 22-012888; NCI-2023-04394; 22-012888
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 14, 2023