Virginia Commonwealth University
Richmond, Virginia, 23286, United States
Location status: Recruiting
NCT Number: NCT07706192
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Richmond, Virginia, 23286, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Participants who receive usual-care referrals but not food packages.
Other names: Comparison Cohort
Time frame: 6 months following enrollment
Percent of participants that self-report of treatment completion
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Virginia Commonwealth University
Other
Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Patients Undergoing Active Treatment
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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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