Back to resultsRoutine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement (RESOURCE)
Primary Purpose
Breast Cancer, Lung Cancer, Gastrointestinal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resource Matching
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer, Lung Cancer, Gastrointestinal Cancer
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
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RESOURCE Matching
Usual Care
Arm Description
Participants randomized into the intervention arm will receive customized resource matching
Participants randomized into the control group will receive a pre-existing pamphlet detailing DFCI resources
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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)
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04879927
Brief Title
Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
Acronym
RESOURCE
Official Title
Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Gastrointestinal Cancer
Keywords
Breast Cancer, Lung Cancer, Gastrointestinal Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RESOURCE Matching
Arm Type
Experimental
Arm Description
Participants randomized into the intervention arm will receive customized resource matching
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants randomized into the control group will receive a pre-existing pamphlet detailing DFCI resources
Intervention Type
Other
Intervention Name(s)
Resource Matching
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
Patients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources.
Primary Outcome Measure Information:
Title
Number of Patients Treatment Interruption
Description
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Time Frame
30 Days
Title
Number of Patients Treatment Interruption
Description
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Time Frame
90 Days
Title
Number of Patients Treatment Interruption
Description
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Time Frame
180 Days
Title
Rate of Treatment Interruption
Description
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Time Frame
00 Days
Title
Rate of Treatment Interruption
Description
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Time Frame
90 Days
Title
Rate of Treatment Interruption
Description
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Time Frame
180 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine J. McCleary, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
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