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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Standard referrals to community resources will be used for participants randomized to usual care.
interventionNames
Other: Usual Care
type
EXPERIMENTAL
label
Intervention
description
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.
interventionNames
Behavioral: Community Service Navigation
Primary outcomes (2)
measure
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
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
References
Publications (99)
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Change in Social Needs
timeFrame
up to 18 months after baseline assessment
description
Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener. To 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.
measure
Episode Completion (EC).
timeFrame
up to 18 months after baseline assessment
description
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.
Secondary outcomes (10)
measure
Area deprivation index (ADI)
timeFrame
up to 18 months after baseline assessment
description
DI is a tool for assessing an area's socioeconomic conditions. Scores range from 1-100, with lower scores indicating minimal socioeconomic disadvantage and higher scores indicating more socioeconomic disadvantage. This outcome measure will report ADI at 6 and 18 months of rural vs urban participants (based on ZIP codes) after baseline.
measure
Rural Urban Commuting Area (RUCA)
timeFrame
up to 18 months after baseline assessment
description
RUCA assesses urbanization, population density, and commuting. Scores range from 1 to 10, with lower scores indicating more urban areas and higher scores representing more rural areas. This outcome measure will report RUCA at 6 and 18 months of rural vs urban participants (based on ZIP codes) after baseline.
measure
Social Service Utilization
timeFrame
up to 18 months after baseline assessment
description
Social Service Utilization will assess how many study participants utilize 211 social services. This outcome measure will report the proportion of participants utilizing the following 211 medical care services: Finding healthy food, Adult education/job training/employment, Clothing/supplies, Housing, Transportation, Paying for health care, Paying bills, Child care, Other, 211 didn't help me get any services. This outcome measure will report social service utilization at 1, 6, and 18 months after the baseline assessment.
measure
Breast cancer risk (Tyrer-Cuzick)
timeFrame
up to 18 months after baseline assessment
description
The Tyrer-Cuzick breast cancer risk score estimates the likelihood of developing breast cancer. Scores range from 0 to 100 with lower scores indicating low breast cancer risk and high scores indicating high breast cancer risk. This outcome measure will report the mean breast cancer risk score at 6 and 18 months after the baseline assessment.
measure
General Health Status
timeFrame
up to 18 months after baseline assessment
description
General Health Status is a scale assessing general health. Scores range from 0 to 5, with lower scores indicating better health and higher scores indicating worse health. This outcome measure will report General Health Status at 1, 6, and 18 months after the baseline assessment.
measure
Self-Report Generated Charlson Comorbidity Index
timeFrame
up to 18 months after baseline assessment
description
Charlson Comorbidity Index is a score predicting mortality risk based on comorbidities. Scores range from 1 to 37, with lower scores indicating better mortality risk and higher scores representing worse mortality risk.
This outcome measure will report the mean Charlson Comorbidity Index at 6 and 18 months after the baseline assessment.
measure
Preventive services visits
timeFrame
from baseline assessment, up to 18 months
description
Preventive services visits will measure how many participants complete their preventive visits. This outcome measure will report the proportion of participants who completed preventive visits such as the next annual mammogram, cervical cancer screening, or colorectal cancer screening. This outcome measure will report the proportion completing preventive services visits at 1, 6, and 18 months after the baseline assessment.
measure
PROMIS Global Health
timeFrame
up to 18 months after baseline assessment
description
PROMIS Global Health is a questionnaire assessing participants' health. Scores range from 0 to 32, with lower scores indicating worse health and higher scores indicating better health. This outcome measure will report PROMIS Global Health at 1, 6, and 18 months after the baseline assessment.
measure
PROMIS Depression
timeFrame
up to 18 months after baseline assessment
description
PROMIS Depression is a questionnaire assessing participants' mental health. Scores range from 0 to 32, with lower scores indicating better mental health and higher scores indicating worse mental health. This outcome measure will report PROMIS Depression at 1, 6, and 18 months after the baseline assessment.
measure
Health Care Access
timeFrame
up to 18 months after baseline assessment
description
Healthcare access is a 4-item questionnaire assessing patients' access to healthcare. Scores range from 0-12, with lower scores indicating worse access to healthcare and higher scores indicating better access to healthcare. This outcome measure will report Health Care Access at 6 and 18 months after the baseline assessment.
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DERIVEDBeck K, Mitchell M, Wallace AS, Freer PE, Wong B, Kepka D, Watt MH, McNall S, Kolomaya A, Ariotti A, Mulford M, Onega T, Ozanne EM. Community navigation intervention for social needs in patients with abnormal mammography: a randomized controlled trial study protocol. BMC Public Health. 2025 Aug 26;25(1):2926. doi: 10.1186/s12889-025-24372-x. PMID 40859259