Clinical trial NCT05301114: Social Risk Factors and Discrimination in Cancer Survivorship
Official title: Scaling Social Determinants of Health Screening, Social Support, and Anti-Racism Training to Reduce Inequities in Minority Cancer Survivor Health and Well-Being in Washington, D.C.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Determinants of Health
Breast Cancer
Prostate Cancer
Health Equity
Disparities
Keywords: Health Equity
Community Health Worker
Social Support
Community Based Organizations
Social Determinants of Health
Breast Cancer
Prostate Cancer
Health Disparities
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: George Washington University
name: Howard University
name: Georgetown University
First posted: 2022-03-29
Enrollment: 1116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the proposed study is to scale social risk factor screening and referral for cancer survivors and to solidify information exchange between clinical and community settings in order to improve survivor health and well-being. This will be completed through three primary aims: 1) To ascertain workflow and map community resources needed to facilitate social risk factor screening and referral for breast and prostate cancer survivors in Washington, District of Columbia. 2) To determine impact of Community Health Worker (CHW) support on Black breast and prostate cancer survivor health and wellbeing as measured through quality of life (QOL) and social connection. 3) To determine impact of anti-racism training for staff and clinicians at three cancer centers on patient-reported discrimination.

Detailed description: Despite improvements in cancer outcomes over time, significant disparities remain between Black and White cancer survivors. It is estimated that clinical care, including access to care and quality of care, accounts for an estimated 20% of health outcomes, while other factors, including social determinants of health (SDoH) and an individual's social risk factors, explain 80% of health outcomes. The goal of this research is thus to simultaneously target unequitable health care systems and accelerate the evidence base for scalable social determinants of health screening and referral to reduce inequities in cancer survivor health and well-being. This project is intended to establish sustainable clinical-community linkages and improve survivor health and well-being. Understanding the burden of social needs in this population, the available community resources, and solidifying integrated, closed-loop referral systems to address those needs is critical to improving quality of life for cancer survivors. The long-term goal of this research is to develop scalable interventions to address social needs and support for cancer survivors.

The study aims to: 1) improve care coordination and information exchange through mapping available resources for cancer survivors across Washington DC and building a universal screening and referral process at three cancer centers in DC; 2) determine impact of Community Health Worker (CHWs) support on cancer survivor health and wellbeing as measured through social connection and quality of life; 3) determine impact of anti-racism (inclusive of SDOH) training for staff and clinicians at three cancer centers on provider cultural competency and patient reported perceived discrimination.

Furthermore, this work evaluates the implementation, impact, and causal mechanisms of SDOH collection and referral to reduce racial inequities among cancer survivors. The investigators include innovative approaches to linking clinics and communities drawing on systems engineering and social network analyses and supported by ongoing DC efforts to bolster health information exchange systems to address social needs. Our approach is also integrated with existing community resources including key community-based organizations in the Washington DC region.

Results from this study will provide the foundation for future research examining the intervention's generalizability to other marginalized cancer survivors and sustainability of the proposed screening and referral system. Findings will also provide a basis for further research on community health workers to support our target population, to improve shared resources in supporting cancer survivors, and to maintain relevance within the evolving health information exchange environment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage I-III breast or prostate cancer and completed curative treatment (surgery, radiation, chemotherapy) or finalized treatment plan (e.g. watch and wait); OR Stage IV breast or prostate cancer approximately 6 months from diagnosis
* Black or African American race

Primary outcomes:
measure: Patient Self-Efficacy
timeFrame: 6 months
measure: Health-related quality of life (QOL)
timeFrame: 6 months
measure: Social connectedness
timeFrame: 6 months
measure: Acceptability of the CHW intervention
timeFrame: 12 months
measure: Appropriateness of the CHW intervention
timeFrame: 12 months
measure: Feasibility of the CHW intervention
timeFrame: 12 months
measure: Sustainability Assessment
timeFrame: 12 months
Secondary outcomes:
measure: Social risk factors
timeFrame: 3 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Hannah Arem, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Mandi Pratt-Chapman, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Hahn EA, Devellis RF, Bode RK, Garcia SF, Castel LD, Eisen SV, Bosworth HB, Heinemann AW, Rothrock N, Cella D; PROMIS Cooperative Group. Measuring social health in the patient-reported outcomes measurement information system (PROMIS): item bank development and testing. Qual Life Res. 2010 Sep;19(7):1035-44. doi: 10.1007/s11136-010-9654-0. Epub 2010 Apr 25.