This clinical trial compares the effect of passive referrals to direct referrals in helping underserved women with their health and social needs after an abnormal mammogram. In the United States (US), breast cancer is the most common and second most deadly cancer in women, with an estimated 281,550 new breast cancer diagnoses and 43,600 breast cancer deaths in 2021. Underserved women, those who do not have adequate access to medical care, are represented disproportionately in those deaths, having lower breast cancer rates but higher death rates. While US breast cancer death rates have decreased approximately 2% per year since 1990, socially and economically disadvantaged women have experienced increasing breast cancer death over that time. Both rural and Latina women are more likely to experience care delays and are up to 1.5 times more likely to be diagnosed with advanced stages of disease compared with urban and non-Latina white women. Improving health equity has become a top national agenda. United Way 211 (211) is a service that can help women connect to community resources to help with their health and social needs after they get a mammogram. Using direct referrals to 211 may help women better with their health and social needs after an abnormal mammogram.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06305312.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Elissa M. Ozanne
Phone: 801-213-4130
PRIMARY OBJECTIVES:
I. 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). (Aim 1)
II. Determine the impact of the community services navigation intervention on breast cancer screening episode completion and preventive care utilization among women with self-reported social needs. (Aim 2)
III. Qualitatively examine multilevel facilitators and barriers to successful engagement with community services and episode completion among underserved women with an abnormal breast cancer screen and self-reported social needs, and explore the role of community service navigation. (Aim 3)
OUTLINE:
AIM 1 & 2: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive usual care, which includes a passive referral to 211 through an informational card providing information to reach out to 211 to request help with community services on study.
GROUP II: Patients receive a direct referral to 211. Patients demographics and social needs are directly communicated to 211 information specialists (ISs) and ISs conduct outreach to patients within 48 hours of referral and two weeks after initial contact to provide help with community services on study.
After completion of study intervention, patients are followed up at 1 month, 6 months and 18 months.
AIM 3: Patients may complete an interview during follow up and clinicians and service providers attend focus groups on study.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorElissa M. Ozanne
