Actively Recruiting

Phase Not Applicable
Age: 8Years - 80Years
All Genders
ID06802406

Nutrition OUtReach In Systems of Healthcare to Address Food Insecurity in Patients Undergoing Transplant and Cellular Therapy

Led by University of Kansas Medical Center · Updated on 2026-04-20

210

Participants Needed

4

Research Sites

39 weeks

Total Duration

On this page

Sponsors

U

University of Kansas Medical Center

Lead Sponsor

D

Duke University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Nutrition OUtReach In Systems of Healthcare

Who Can Participate

Age: 8Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planning to receive transplant or cell therapy
  • Screen positive for food insecurity by answering "often true" or "sometimes true" to questions about food running out or not lasting in the past 12 months
  • Age between 8 and 80 years
  • Able to read and write English or Spanish
Not Eligible

You will not qualify if you...

  • Patients who do not tolerate oral nutrition at the time of study enrollment

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 4 locations

1

Stanford University

Stanford, California, United States, 94305

Not Yet Recruiting

2

University of Kansas Cancer Center

Fairway, Kansas, United States, 66205

Actively Recruiting

3

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Not Yet Recruiting

4

Duke University

Durham, North Carolina, United States, 27705

Not Yet Recruiting

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Research Team

A

Anthony Sung, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Financial Toxicity and Quality of Life in Patients Undergoing Stem-Cell Transplant Evaluation: A Single-Center Analysis.

S M Qasim Hussaini, Yi Ren, Alessandro Racioppi...

https://pubmed.ncbi.nlm.nih.gov/38127876

The World Cancer Research Fund/American Institute for Cancer Research Third Expert Report on Diet, Nutrition, Physical Activity, and Cancer: Impact and Future Directions.

Steven K Clinton, Edward L Giovannucci, Stephen D Hursting

https://pubmed.ncbi.nlm.nih.gov/31758189

Further Guidance in Implementing the Standardized 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Score.

Marissa M Shams-White, Dora Romaguera, Panagiota Mitrou...

https://pubmed.ncbi.nlm.nih.gov/32152215

Operationalizing the 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Cancer Prevention Recommendations: A Standardized Scoring System.

Marissa M Shams-White, Nigel T Brockton, Panagiota Mitrou...

https://pubmed.ncbi.nlm.nih.gov/31336836