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

Breast Cancer Clinical Trial

— RESOURCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879927
• Other study ID #: 20-437
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Lung Cancer

Intervention

Other:
• 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.
• Usual Care
Patients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Treatment Interruption	Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)	30 Days
Primary	Number of Patients Treatment Interruption	Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)	90 Days
Primary	Number of Patients Treatment Interruption	Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)	180 Days
Primary	Rate of Treatment Interruption	Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)	00 Days
Primary	Rate of Treatment Interruption	Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)	90 Days
Primary	Rate of Treatment Interruption	Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)	180 Days