Food for Health Equity: Evaluation of a Nutrition Assistance Program

March 15, 2025 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

Status

Completed

Conditions

Intervention / Treatment

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 (Actual)

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 Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: Nutrition Assistance 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Insecurity
Time Frame: Baseline to 6 months
Assessed using the validated 2-item Hunger Vital Sign, 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. One or more affirmative responses indicate food insecurity.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Security
Time Frame: Baseline to 6 months

Assessed using the validated United States Department of Agriculture (USDA) Six Item Food Security Survey will be administered to participants at time of enrollment and again at 6-months post-enrollment.

Rabbit MP, Hales LJ, Reed-Jones M. Survey Tools. Accessed October 16, 2024, 2024. https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/survey-tools/#six
Baseline to 6 months
Health-related quality of life (HRQOL)
Time Frame: Baseline to 6 months

Assessed using the 27-item validated Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The questionnaire has a scale of 0-108, with higher scores correlating with better quality of life.

Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 1993/03// 1993;11(3):570-579. doi:10.1200/jco.1993.11.3.570
Baseline to 6 months
Financial Toxicity
Time Frame: Baseline to 6 months

Assessed using the 12-item Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) score. Scores range from 0-44 with higher scores correlating with better financial well-being.

de Souza JA, Yap BJ, Wroblewski K, et al. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. Feb 1 2017;123(3):476-484. doi:10.1002/cncr.30369
Baseline to 6 months
Health-related social needs
Time Frame: Baseline to 6 months
Assessed using the validated 13-item the Accountable Health Communities (AHC) Health-Related Social Needs Screening Tool from the Center for Medicare and Medicaid Services. Each question is scored from 1 to 5, based on the response option, scores are tallied. Totals range from 4 to 20. Higher scores indicate greater health-related social needs.
Baseline to 6 months
Satisfaction with the intervention
Time Frame: Baseline to 6 months
Assessed using a 5-question tool where patients rated their satisfaction with the quality of intervention components and likelihood to recommend it to others. Scores were summed and higher scores indicated greater satisfaction.
Baseline to 6 months
Treatment Adherence
Time Frame: Baseline to 6 months
Using a 1-item dichotomous question on treatment adherence. Adherence to cancer treatment was defined as having no missed scheduled clinic or treatment visits, which was abstracted from the electronic health record.
Baseline to 6 months

Collaborators and Investigators

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

Sponsor

Stanford University

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 (Actual)

May 15, 2024

Study Completion (Actual)

February 15, 2025

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 25, 2025

Last Update Submitted That Met QC Criteria

March 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

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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