Community Services Navigation to Advance Health Equity in Breast Cancer Screening

Breast Cancer Clinical Trial

— B-SINCERE  

Official title:

Community Services Navigation to Advance Health Equity in Breast Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305312
• Other study ID #: HCI166685
• Secondary ID: 1R01CA282409-01
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: September 2028

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Elissa Ozanne, PhD
• Phone: 801-213-4130
• Email: Elissa.Ozanne[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1450
• Est. completion date: September 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English and Spanish speakers

• Received an abnormal result of a screening mammogram

• Self-reports at least one social need on the B-SINCERE Screener

Exclusion Criteria:

-Prior diagnosis of breast cancer

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Community Service Navigation
Patients randomized to the intervention will be directly referred to the United Way of Salt Lake's 211 community referral service for additional outreach.

Other:
• Usual Care
Standard referral to community resources.

Locations

Country	Name	City	State
United States	University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener	Test whether the use of a community services navigation intervention in conjunction with social service referrals decreases social needs compared to the referrals alone (usual care). B-SINCERE, reported on a 0-10 point scale, with 0=No Social Needs present, and 1-10=Social Needs present, anything greater than 0 indicates social needs and eligibility for the study.	18 months
Primary	Episode Completion (EC). EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed.	Impact of the community services navigation intervention on breast cancer screening episode completion and preventive care utilization among women with self-reported social needs. Preventive Care Utilization is a descriptive measure that is not reporting a score on a scale.	18 months