Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement

NCT ID: NCT04879927

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2023-04-01

Brief Summary

The purpose of this research is to understand how screening for patient resource needs followed by customized resource matching can improve outcomes for adults with breast, lung or gastrointestinal cancer.

Detailed Description

This research study is an intervention assessment; this is the first-time investigators are examining the impact of screening for resource needs followed by customized resource matching at Dana-Farber Cancer Institute.

• The research study procedures include screening for social determinants of health (resource) needs and, depending on study group, resource matching.
• Participants will be randomized into one of two groups.

• Usual Care or Usual Care with customized resource matching.

It is expected that about 125 participants will take part in this research study.

Conditions

Breast Cancer; Lung Cancer; Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

RESOURCE Matching

Participants randomized into the intervention arm will receive customized resource matching

Group Type: EXPERIMENTAL

Resource Matching

Intervention Type: OTHER

Resource staff involved in the customized resource matching arm of the intervention will include staff from DFCI Patient Services and DFCI Financial Counseling. Financial counseling will support patients with financial resource needs. DFCI Patient Services will provide assistance for all other patient Social Determinants of Health needs.

Usual Care

Participants randomized into the control group will receive a pre-existing pamphlet detailing DFCI resources

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Patients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources.

Interventions

Resource Matching

Resource staff involved in the customized resource matching arm of the intervention will include staff from DFCI Patient Services and DFCI Financial Counseling. Financial counseling will support patients with financial resource needs. DFCI Patient Services will provide assistance for all other patient Social Determinants of Health needs.

Intervention Type: OTHER

Usual Care

Patients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Eligible patients will be adults age 18 or older, able to consent, scheduled for a new patient consultation in DFCI BOC, TOP or GCC. To select for patients from demographic groups vulnerable to SDoH needs, two different groups will be eligible to participate.
• Group A

• BIPOC (Black, Latinx, Native American or Pacific Islander)
• LEP Spanish-speaking (As indicated by the EHR)
• Low SES (from zip code with median household income <$32,000/year) OR
• Age 70+
• Group B

• Any one NPIQ response indicating SDoH need
• Health literacy/numeracy, Caregiving/relationships, OR Finances

Exclusion Criteria

• Group A and B

-- Patients not continuing care at Dana Farber Cancer Institute

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Nadine McCleary, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadine J. McCleary, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

20-437

Identifier Type: -

Identifier Source: org_study_id