Social Risk Factors and Discrimination in Cancer Survivorship

October 17, 2023 updated by: Medstar Health Research Institute

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention participants
Among patients who completed the social needs screening as a part of standard of care, all stage I-IV Black cancer survivors will be invited to participate in a six-month community health worker intervention. The community health worker will assess social needs and provide six months of support.
Behavioral: Community Health Worker support
Participant will receive weekly or monthly support (via phone or in person) from a community health worker. The community health worker will be responsible for continuously assessing the patient's social needs, providing referrals to community based organizations, and assisting with the patient's non-medical needs as they progress through survivorship (e.g. social support, referrals, etc). Individuals who identify no risk factor will receive monthly phone calls, while individuals who identify 1-3 risk factors will receive monthly home visits with interim phone calls for 6 months. Those who identify 4 or more risk factors or have intensive needs such as behavioral health will receive the same services as the medium risk group and will also be connected with the social work teams within each institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Self-Efficacy
Time Frame: 6 months
This study will use the following Patient-Reported Outcomes Measurement Information System® (PROMIS) self-efficacy for managing chronic conditions 4-item measures: managing daily activities, managing emotions, managing medications and treatments, and managing social interactions. The minimum score on these overall scales is a 16 and the maximum score is 80, in which a higher number represents a higher level of self-efficacy for managing chronic conditions. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
6 months
Social connectedness
Time Frame: 6 months
To measure social connectedness, this study will draw from the item banks for the following Patient-Reported Outcomes Measurement Information System® (PROMIS) 2.0 adult item measures: Social Isolation, Emotional Support, Informational Support, and Instrumental Support. Each scale is scored with a minimum score of 4 and a maximum score of 20, in which higher scores represent higher levels of social isolation, emotional support, instrumental support, and informational support, respectively. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
6 months
Acceptability of the CHW intervention
Time Frame: 12 months
A four-item Likert scale will be delivered to relevant clinicians to provide feedback on acceptability of the intervention
12 months
Appropriateness of the CHW intervention
Time Frame: 12 months
A four-item Likert scale will be delivered to relevant providers to provide feedback on appropriateness of the intervention, whereby higher scores indicate greater perceived appropriateness.
12 months
Feasibility of the CHW intervention
Time Frame: 12 months
A four-item Likert scale will be delivered to relevant providers to provide feedback on feasibility of the intervention, whereby higher scores indicate greater perceived feasibility.
12 months
Sustainability Assessment
Time Frame: 12 months
This study will use the Program Sustainability Assessment Tool annually to assess environmental support, funding stability, partnerships, organizational capacity, program evaluation, program adaptation, communications and strategic planning. The minimum score for this evaluation is 0 and the maximum score is 56. A higher score represents a higher level of program sustainability. Individual categories can also be assessed with a minimum score of 0 and a maximum score of 7 in each, in which a higher score represents higher sustainability in that category.
12 months
Health-related quality of life (QOL)
Time Frame: 6 months
QOL will be measured using the Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 computer adaptive test, a collection of 4-item adaptive forms assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, as well as a single global pain item. For the 4-item forms, the lowest score is 4 and the highest score is 16. Higher scores represent higher levels of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, respectively. The single pain item has a minimum score of 0 and a maximum score of 10, in which a higher score represents a higher level of pain. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social risk factors
Time Frame: 3 months
Social risk factors screeners will be administered on the following domains: food insecurity, housing instability, utilities, paying for the basics, employment, transportation, and mental health. These scales are measured uniquely to the electronic health record systems in which they are implemented. Each need is assigned a single point and summed for an overall score.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

Georgetown University
George Washington University
Howard University

Investigators

  • Principal Investigator: Hannah Arem, PhD, MedStar Health Research Institute
  • Principal Investigator: Mandi Pratt-Chapman, PhD, George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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