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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Food Assistance Program

    Other intervention

    Participants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months

  • Standard of Care

    Other intervention

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

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Food Assistance ProgramExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.

Percent of participants that self-report of treatment completion

Time frame
6 months following enrollment

Secondary outcomes

1

Change in Food Insecurity Score

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.

Time frame
Baseline and 6 month follow-up
2

Change in Quality of Life (QOL) using European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-30)

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.

Time frame
Baseline and 6 month follow-up
3

Change in financial toxicity

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.

Time frame
Baseline and 6 month follow-up

Other outcomes

Sponsors and contacts

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