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NCT Number: NCT07706192

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23286, United States

Location status: Recruiting

Location contact

Massey CTO CPC Team

CONTACT

[email protected]

804-628-6430

Susan Hong, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Food Assistance Program

Other

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

Standard of care

Other

Participants who receive usual-care referrals but not food packages.

Other names: Comparison Cohort

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Massey CTO CPC Team

CONTACT

[email protected]

804-628-6430

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

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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