Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Pts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Food Assistance Program, Standard of Care.
- Who it may be relevant to
- Registry conditions: Treatment Adherence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Patients Undergoing Active Treatment
Overview
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.
Interventions
- 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 Standard of Care
Participants who receive usual-care referrals but not food packages.
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Change in Food Insecurity Score [Time frame: 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]
- Change in financial toxicity [Time frame: Baseline and 6 month follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Virginia Commonwealth University — Richmond
Identifiers
NCT: NCT07706192 · MCC-25-22644