NCT05947357

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

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

July 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

July 7, 2023

Last Update Submit

March 15, 2025

Conditions

Keywords

Food InsecurityFood Assistance Quality Improvement ProgramLatinx and minority patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Food Security

    Baseline to 6 months

  • Health-related quality of life (HRQOL)

    Baseline to 6 months

  • Financial Toxicity

    Baseline to 6 months

  • Health-related social needs

    Baseline to 6 months

  • Satisfaction with the intervention

    Baseline to 6 months

  • +1 more secondary outcomes

Study Arms (1)

Nutrition Assistance Program

EXPERIMENTAL

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

Interventions

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.

Nutrition Assistance Program

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Food Assistance

Intervention Hierarchy (Ancestors)

Public AssistanceFinancing, GovernmentFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Patients as part of a nutrition assistance program will randomly receive food vouchers for $40.00 each month for use in the produce section of local grocery stores for 6 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 17, 2023

Study Start

July 15, 2023

Primary Completion

May 15, 2024

Study Completion

February 15, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations