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Completed

NCT Number: NCT05947357

Food for Health Equity: Evaluation of a Nutrition Assistance Program

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Assistance Program

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Addressing LatinX Cancer Care Equity: Food for Health Equity

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 17, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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