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Anne E Holland, Martijn A Spruit, Thierry Troosters...
https://pubmed.ncbi.nlm.nih.gov/25359355/Actively Recruiting
Led by University of Kansas Medical Center · Updated on 2026-04-20
210
Participants Needed
4
Research Sites
39 weeks
Total Duration
Food insecurity, meaning not having consistent access to enough food due to limited resources, affects many American households and is worse among patients with serious medical conditions. This research aims to find out if giving patients bags of food during clinic visits can improve nutrition, lower costs, and lead to better outcomes for patients undergoing transplant and cellular therapy for blood cancers. The study focuses on patients who often move away from home and are at high risk for nutrition problems and other complications. Participants are randomly assigned to two groups one receives standard information about local food banks, and the other is given bags of shelf-stable food during clinic visits twice a week, along with educational materials like recipes and videos. This approach delivers food directly in the healthcare setting to reduce barriers such as extra trips and stigma. The study will run from 2025 to 2029 and compares these approaches to see if they improve patient health and reduce costs. During the study, patients will be monitored closely with assessments through day 100 and up to one year, including nutrition status, infections, graft-versus-host disease, relapse, survival, quality of life, financial stress, physical and mental function, dietary habits, social factors, and frailty. The research team will collect data from patient reports, clinical evaluations, and questionnaires to understand the impact of providing food assistance in this setting and support lasting healthcare-community partnerships.
CONDITIONS
Nutrition OUtReach In Systems of Healthcare
A
Anthony Sung, MD
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University of Kansas Medical Center
Lead Sponsor
Duke University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Food Bags (Structured Food Assistance) | Information and Education Only | Usual Supportive Care (No Structured Food Intervention) |
|---|---|---|---|
| What it is | Participants receive bags of shelf-stable food twice a week, with recipes, handouts, and videos for food-related education during transplant or cell therapy. | Participants receive information, recipes, and educational materials related to nutrition but do not receive food bags. | Usual supportive care typically does not include structured food bag provision or standardized food insecurity interventions for transplant/cell therapy patients. |
| Role in trial | Investigational arm: structured nutrition support beyond education. | Control arm: education and information without additional food provision. | Reflects current routine practice outside the trial. |
| Primary use or goal | Addresses food insecurity in peri-transplant patients by providing direct nutritional support and education, aiming to reduce malnutrition. | Provides general nutrition knowledge and education to address food insecurity, without directly offering extra food assistance. | Supportive care may provide nutritional counseling if requested but rarely addresses food insecurity with direct interventions. |
| How it is given or performed | Participants collect bags of shelf-stable food for 2-3 days twice weekly during clinic visits. Additional recipes, handouts, and food-preparation videos are provided. | Educational materials and recipes are provided without direct food support during clinic visits. | No standard process for food insecurity screening or intervention. Nutritional counseling or social work referrals may occur only if food insecurity is identified. |
| Evidence status | Efficacy under investigation. This is an ongoing randomized trial evaluating if structured food assistance reduces peri-transplant malnutrition. | No proven efficacy; functions as study control for comparison to food bag arm. | No high-quality evidence that routine supportive care without structured food assistance prevents malnutrition among food-insecure transplant patients. |
| Important limitations | Results have not yet been reported. Food bags may not address all barriers to nutrition such as taste changes, swallowing issues, or financial constraints beyond food. | Education alone may have limited impact for food-insecure patients who need direct food resources. | Routine care rarely screens for food insecurity and often fails to provide interventions even when needs are present. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 100 days
Participants receive bags of shelf-stable food for 2-3 days for one individual twice a week in clinic, along with recipes, handouts, and videos to support education and food preparation. Participants in the information group receive information on local food banks according to standard care.
Twice weekly visits in clinic
Duration - Up to 1 year
Participants are monitored for outcomes including infection incidence, graft-versus-host disease, relapse, survival, quality of life, and food insecurity up to one year after transplant or cell therapy.
Visits at Day 100 and Year 1
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/26267444/University of Kansas Medical Center
Lead Sponsor
Duke University
Collaborating Sponsor