Recruiting

Health Equity

Sponsor:

University of Utah

Code:

NCT06305312

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Community Service Navigation

Usual Care

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT06305312

Start date

Apr 30, 2024

Status verified date

Jul, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • Patients who are currently in treatment for breast cancer
  • Patients with a normal screening result.
  • Patients who do not exhibit at least 1 social need according to their SINCERE screening result.
  • Patients who don't speak English or Spanish
  • Cognitive limitations that impede informed consent
  • Patients living outside of Utah

Study Design

Enrollment

1450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Usual Care

Standard referrals to community resources will be used for participants randomized to usual care.

experimental: Intervention

Community Services Navigation with 211 Information Specialists (ISs) will conduct outreach to participants within 48 hours of referral through telephone, text, or email, depending on patient preference. Two weeks after initial contact ISs follow up with patients to provide additional support and document use of the referred services in ServicePoint.

Interventions

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.

Usual Care

Standard referral to community resources.

Primary outcome measure

  • Change in Social Needs [ Time Frame: up to 18 months after baseline assessment ]
  • Episode Completion (EC). [ Time Frame: up to 18 months after baseline assessment ]

Central Contacts and Locations

Central contacts

Elissa Ozanne, PhD

801-213-4130Elissa.Ozanne@hsc.utah.edu

Locations

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Elissa Ozanne, PhD

801-213-4130Elissa.Ozanne@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-08-01.