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

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04879927
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28.5
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Lung Cancer; Gastrointestinal Cancer	Other: Resource Matching; Other: Usual Care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
• Actual Study Start Date: May 17, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Patients Treatment Interruption [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)

2. Number of Patients Treatment Interruption [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)

3. 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)

4. Rate of Treatment Interruption [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)

5. Rate of Treatment Interruption [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)

6. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Dana-Farber Cancer Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nadine McCleary MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT04879927
• Other Study ID Numbers: 20-437
• First Posted: May 10, 2021
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nadine McCleary MD, MPH, Principal Investigator, Dana-Farber Cancer Institute: Breast Cancer; Lung Cancer; Gastrointestinal Cancer
• Additional relevant MeSH terms: Gastrointestinal Neoplasms

Study Results

No Results Posted as of Aug 16, 2022