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

May 1, 2023 updated by: Nadine McCleary, MD, MPH, Dana-Farber Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

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 Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

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:

  • 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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RESOURCE Matching
Participants randomized into the intervention arm will receive customized resource matching
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.
Active Comparator: Usual Care
Participants randomized into the control group will receive a pre-existing pamphlet detailing DFCI resources
Other: Usual Care
Patients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Treatment Interruption
Time Frame: 30 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)
30 Days
Number of Patients Treatment Interruption
Time Frame: 90 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)
90 Days
Number of Patients Treatment Interruption
Time Frame: 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)
180 Days
Rate of Treatment Interruption
Time Frame: 00 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)
00 Days
Rate of Treatment Interruption
Time Frame: 90 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)
90 Days
Rate of Treatment Interruption
Time Frame: 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)
180 Days

Collaborators and Investigators

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

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Nadine J. McCleary, MD, MPH, Dana-Farber Cancer Institute

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 17, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

Clinical Trials on Breast Cancer

Clinical Trials on Resource Matching

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe