- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05947357
Food for Health Equity: Evaluation of a Nutrition Assistance Program
March 19, 2024 updated by: Manali Indravadan Patel, Stanford University
Addressing LatinX Cancer Care Equity: Food for Health Equity
This study seeks to evaluate whether a nutrition assistance quality improvement program for patients with cancer and food insecurity receiving active treatment at Pacific Cancer Care will have reductions in food insecurity.
Study Overview
Detailed Description
This study seeks to evaluate the effectiveness and patient satisfaction with a nutrition assistance quality improvement program in which a randomly selected 30 patients will receive a food voucher with $40.00 each month for 6 months for use in the produce section at local grocery stores in the county.
The primary outcome is understanding whether this program is effective at reducing food insecurity among patients being treated for cancer and will provide key insights that may guide program expansion or improvement.
Study Type
Interventional
Enrollment (Estimated)
30
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 Contact
- Name: Manali A Patel
- Phone Number: 6504859462
- Email: manalip@stanford.edu
Study Contact Backup
- Name: Emily H Wood
- Phone Number: 3106216050
- Email: ehwood@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University School of Medicine
-
Contact:
- Manali I Patel, MD MPH MS
- Phone Number: 650-723-4000
- Email: manalip@stanford.edu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient Participants must be undergoing or starting treatment for cancer at the Pacific Cancer Care clinic who screen positive for food insecurity using at 2-item screener, speak English or Spanish, have capacity to consent (e.g. no dementia or other cognitive impairment), are Latinx or another racial and ethnic minority group OR low income, have public insurance, OR are insured by an agricultural company sponsored health insurance
Exclusion Criteria:
- Patients will be ineligible if they do not have a current cancer diagnosis, cannot communicate in English or Spanish, are deemed ineligible to consent, are under 18 years of age, are not Latinx or another racial/ethnic minority OR are not low income OR are not publicly insured, uninsured, or do not have health insurance from an agricultural company
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nutrition Assistance Program
A total of 30 Latinx cancer patients on active cancer treatment who have screened positive for food insecurity will receive a $40.00 voucher for use each month for 6 months for nutrition assistance in the produce section of local grocery stores after enrollment in the program.
|
Patients will receive in the intervention group a $40.00 per month voucher for 6 months for use in the produce section of a local grocery store.
|
No Intervention: Usual Care
A total of 30 patients who have screened positive for food insecurity will receive usual care consisting of referral to the local food bank as part of the nutrition assistance program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Insecurity
Time Frame: Baseline to 6 months
|
A validated six-item short form of the Household Food Security Scale will be administered to participants at time of enrollment and again at 6-months post-enrollment.
Responses to questions "often" and "sometimes" versus "never" which are considered affirmative responses.
Two or more affirmative responses indicate food insecurity, five or more affirmative responses indicates hunger.
|
Baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 15, 2023
Primary Completion (Estimated)
December 15, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
July 7, 2023
First Submitted That Met QC Criteria
July 7, 2023
First Posted (Actual)
July 17, 2023
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 64256
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.
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