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

Not Applicable

Completed

• Conditions: Gastrointestinal Cancer; Breast Cancer; Lung Cancer

• Registration Number: NCT04879927
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-10
• Study Start: 2021-05-17
• Primary Completion: 2022-10-01
• Study Completion: 2023-04-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Patients Treatment Interruption	180 Days	Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Rate of Treatment Interruption	180 Days	Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States