Food for Health Equity: Evaluation of a Nutrition Assistance Program

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: Cancer
• Intervention / Treatment: Other: Nutrition Assistance Program

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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	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	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)	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	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	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	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	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

• Sponsor: Stanford University

Study record dates

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: Food Insecurity; Food Assistance Quality Improvement Program; Latinx and minority patients
• 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