Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Pts

July 9, 2026 updated by: Virginia Commonwealth University

Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Patients Undergoing Active Treatment

Prospective cohort and descriptive study aimed at identifying cancer patients experiencing food insecurity at Virginia Commonwealth University (VCU) Massey Comprehensive Cancer Center. The study will involve evaluating the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

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

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23286
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Susan Hong, MD
        • Contact:

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:

  • Adult patients (≥18 years old) with a current diagnosis of cancer
  • Patients attending outpatient services at the VCU Massey Comprehensive Cancer Center
  • Patients who are willing to participate and provide informed consent
  • Responding "sometimes true" or "often true" to at least one of the two validate Hunger Vital Sign Screening questions

Exclusion Criteria:

  • Patients who are unable to provide informed consent due to cognitive impairment or language barriers
  • Patients who are enrolled in other clinical trials that prohibit participation in additional research
  • Patients who do not consent to being included in the food insecurity registry
  • Patients with medical conditions other than cancer

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Food Assistance Program
Six month food assistance program-shelf-stable food boxes
Other: Food Assistance Program
Participants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months
Other Names:
  • Intervention Cohort
Active Comparator: Standard of Care
Usual-care referrals
Other: Standard of Care
Participants who receive usual-care referrals but not food packages.
Other Names:
  • Comparison Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.
Time Frame: 6 months following enrollment
Percent of participants that self-report of treatment completion
6 months following enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Food Insecurity Score
Time Frame: Baseline and 6 month follow-up

Using the Food Insecurity Assessment: a 2 Question Hunger Vital Signs will be used to assess patient food insecurity status with the following two questions:

"Within the past 12 months, did you worry your food would run out before you got the money to buy more?" "Within the past 12 months, did the food you buy not last and you didn't have money to get more?"

Scoring will categorize patients as never true, sometimes true, or often true. Baseline is defined as when a patient responds SOMETIMES TRUE or OFTEN TRUE to one of the two validated Hunger Vital Sign Screening questions for the first time. Patients will receive an email about the financial impact and QOL validated surveys at each time interval.
Baseline and 6 month follow-up
Change in Quality of Life (QOL) using European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-30)
Time Frame: Baseline and 6 month follow-up

The EORTC QLQ-30 questionnaire is a 30-item, patient-reported instrument designed to assess the health-related quality of life (HRQoL), functional status, and symptom burden of cancer patients. Comprises 30 questions grouped into 5 functional scales, 9 symptom scales/items, and a global health status.

Scoring: Uses a 4-point Likert scale (7-point for global items), transformed to a 0-100 scale. Higher scores indicate better function/QoL, but worse symptom burden.
Baseline and 6 month follow-up
Change in financial toxicity
Time Frame: Baseline and 6 month follow-up
The Functional Assessment of Chronic Illness Therapy for measure of financial toxicity (FACIT-COST) questionnaire to assess the impact of treatment on patient financial status. This measure has 12 questions based on patient reported outcomes to assess financial quality of life stress; numeric responses 0-4; Uses a score range 0-44 with higher scores indicating better Financial Well-Being.
Baseline and 6 month follow-up

Collaborators and Investigators

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

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Susan Hong, MD, Virginia Commonwealth 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 6, 2026

Primary Completion (Estimated)

August 31, 2035

Study Completion (Estimated)

August 31, 2035

Study Registration Dates

First Submitted

July 9, 2026

First Submitted That Met QC Criteria

July 9, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-25-22644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no current plans to share individual patient data.

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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