Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
RESOURCE
1 other identifier
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedMay 3, 2023
May 1, 2023
1.4 years
May 5, 2021
May 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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
Study Arms (2)
RESOURCE Matching
EXPERIMENTALParticipants randomized into the intervention arm will receive customized resource matching
Usual Care
ACTIVE COMPARATORParticipants randomized into the control group will receive a pre-existing pamphlet detailing DFCI resources
Interventions
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.
Patients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Group A and B
- \-- Patients not continuing care at Dana Farber Cancer Institute
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadine J. McCleary, MD, MPH
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 5, 2021
First Posted
May 10, 2021
Study Start
May 17, 2021
Primary Completion
October 1, 2022
Study Completion
April 1, 2023
Last Updated
May 3, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.