Nutrition OUtReach In Systems of Healthcare (NOURISH)

April 14, 2026 updated by: University of Kansas Medical Center

Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult.

By doing this study investigators hope to learn more about whether addressing food insecurity by giving patients bags of food in clinic can help improve nutrition, reduce costs, and improve transplant and cellular therapy outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Food insecurity (FI), defined as a lack of consistent access to enough food for every person in a household to live an active, healthy life due to insufficient money or other resources, affects 17 million (12.8%) of American households. FI is exacerbated in patients with complex medical conditions, and it is associated with worse health outcomes and increased healthcare utilization and costs. Strategies to address FI such as home-delivered meals or food assistance programs like the Supplemental Nutrition Assistance Program (SNAP) and food banks/pantries/pharmacies may improve healthcare outcomes. However, home-delivered meals are associated with higher costs due to individualized delivery while food assistance programs have several barriers to participation. We propose to leverage the strengths of both those approaches in a novel healthcare-community partnership between cancer centers and food banks called Nutrition OUtReach In Systems of Healthcare (NOURISH), to directly deliver food to patients in clinic. Patients, caregivers, dietitians, social workers, nurses, physicians, food bank staff, and community members will work together to determine medically tailored options for the patient population; food banks will oversee sourcing and preparing bags of food; and healthcare providers will distribute bags to patients in clinic after their appointments. Because NOURISH does not require patients to make an extra trip and bags are distributed discreetly to avoid stigma, it increases adoption; because food is handed out in clinic, it lowers costs. We propose to evaluate NOURISH in a multicenter randomized controlled trial in FI patients with hematologic malignancies receiving transplant and cellular therapy (TCT). We chose this population for three reasons: (1) TCT patients are in great need as approximately 75% will relocate to live near a quaternary cancer center (QCC) for a month or more while receiving TCT, removing them from their normal sources of support; (2) TCT patients are at high risk for malnutrition and other adverse outcomes, often struggling with nausea, anorexia, and other side effects that can be exacerbated by FI; (3) TCT may be a model for sustaining care: while other Food is Medicine initiatives have shown economic benefits, because cost savings do not flow to healthcare systems, there is little incentive for implementation. In contrast, TCT is among the most expensive medical procedures, and healthcare systems are typically reimbursed through bundled payments. As a result, QCCs have an incentive to pursue strategies that may lower costs and improve outcomes. For example, many TCT patients with FI will receive total parenteral nutrition, at significant cost. NOURISH may prevent malnutrition and the need for intravenous nutrition through much cheaper food assistance. The success of our randomized controlled trial will provide a compelling rationale for QCCs to continue to fund food banks in their communities, providing much-needed financial support to sustain these partnerships while improving access and outcomes for patients. Furthermore, positive experiences in TCT may lead to the expansion of these healthcare-community partnerships to the broader cancer population and beyond.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Stanford University
        • Principal Investigator:
          • Andrew Rezvani, MD
        • Contact:
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Anthony Sung, MD
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Jonathan Peled, MD
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Not yet recruiting
        • Duke University
        • Principal Investigator:
          • Kris Mahadeo, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Planning to receive transplant or cell therapy

  • Screen positive for food insecurity by answering "often true" or "sometimes true" to one of the following:

    • "Within the past 12 months, you worried that your food would run out before you got money to buy more,"
    • "Within the past 12 months, the food you bought just didn't last and you didn't have money to get more."
  • Age 8 - 80
  • Able to read/write English or Spanish (many patient-reported outcome measures lack validated translations in other languages)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Information Group
These participants will receive information on their local food banks according to standard of care.
Experimental: Food Bags Group
Patients will be given bags of shelf-stable food for 2-3 days for one individual twice a week in clinic. Additionally, they will receive recipes, handouts, and videos to help with education and food preparation.
Other: Food Bags
Participants will receive bags of shelf-stable food for 2-3 days for one individual twice a week in clinic. They will also receive recipes, handouts, and videos to help with education and food preparation.
Other Names:
  • NOURISH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-Transplant and Cell Therapy Malnutrition
Time Frame: Through Day 100
Assessed by Global Leader Initiative on Malnutrition and confirmed by a dietitian
Through Day 100

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-TCT Incidence of Infections
Time Frame: Through Day 100
Incidence and subtypes (blood stream, respiratory, or other) of infections captured as standard of care.
Through Day 100
Peri-TCT Incidence of Acute Graft-vs-Host-Disease
Time Frame: Through Day 180
Incidence of acute GVHD captured as standard of care.
Through Day 180
Peri-TCT Incidence of Chronic Graft-vs-Host Disease
Time Frame: Through Year 1
Incidence of chronic GVHD captured as standard of care.
Through Year 1
Incidence of Relapse
Time Frame: Through Year 1
Incidence of relapse captured as standard of care.
Through Year 1
Incidence of Treatment-Related Mortality
Time Frame: Through End of Study
Incidence of treatment-related mortality captured as standard of care.
Through End of Study
Overall Survival
Time Frame: Through Year 1
Overall survival captured as standard of care.
Through Year 1
Financial Toxicity
Time Frame: Day 100 and Year 1
Financial toxicity measured by average Functional Assessment in Chronic Illness Therapy-COST: A FACIT Measure of Financial Toxicity (FACIT-COST) score. The FACIT-COST result scale ranges from a minimum of 0 to a maximum of 44, with a higher number representing better financial well-being.
Day 100 and Year 1
Physical Function
Time Frame: At Day 100 and at Year 1
Physical function measured by average 6 minute walk test distance.
At Day 100 and at Year 1
Cognitive Function
Time Frame: At Day 100 and at Year 1
Cognitive function measured by average MOntreal Cognitive Assessment (MOCA) score. The MOCA score ranges from a minimum of 0 to a maximum of 30, with a higher score indicating better cognitive function.
At Day 100 and at Year 1
Mental Health
Time Frame: At Day 100 and at Year 1
Mental health as measured by percentage of patients who are positive on the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 uses a scale ranging from a minimum of 0 to a maximum of 27, interpreted as 1-13: mild depression; 14-19: moderate depression; and 20-27: severe depression.
At Day 100 and at Year 1
Dietary Habits and Consumption
Time Frame: At Year 1
Dietary habits and consumption measured by overall diet quality scores assessed using the Healthy Eating Index (HEI)-2020. The HEI-2020 uses a scale ranging from a minimum of 0 to a maximum of 100, with a higher number indicating a diet more closely aligned with recommended dietary guidelines.
At Year 1
Dietary Habits and Consumption
Time Frame: At Year 1
Dietary habits and consumption measured by overall diet quality scores assessed using the National Cancer Institute (NCI) Multi-Factor Screener. The NCI Multifactor Screener provides an estimate of intake of percent energy from fat consumed per day.
At Year 1
Dietary Habits and Consumption
Time Frame: At Year 1
Dietary habits and consumption measured by overall diet quality scores assessed using the National Cancer Institute (NCI) Multi-Factor Screener. The NCI Multifactor Screener provides an intake estimate of fiber (grams) consumed per day.
At Year 1
Dietary Habits and Consumption
Time Frame: At Year 1
Dietary habits and consumption measured by overall diet quality scores assessed using the National Cancer Institute (NCI) Multi-Factor Screener. The NCI Multifactor Screener provides an estimate of fruit and vegetable intake (servings) consumed per day.
At Year 1
Dietary Habits and Consumption
Time Frame: At Year 1
Dietary habits and consumption measured by overall diet quality scores assessed using the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Cancer Prevention Score. The WCRF/AICR Cancer Prevention Score ranges from a minimum of 0 to a maximum of 10, with a higher number representing greater adherence to cancer prevention recommendations.
At Year 1
Impact on Food Insecurity
Time Frame: At Year 1
Measured by the United States Department of Agriculture Adult Food Security Module (USDA AFSM) Short Form survey. The USDA AFSM Short Form Survey uses a raw scoring scale from a minimum of 0 to a maximum of 6, with a higher number indicating greater food insecurity.
At Year 1
Social Determinants of Health
Time Frame: At workup and at Year 1
Social determinants of health measured by the Centers for Medicare & Medicaid Services Accountable Health Communities Health Related Social Needs (CMS AHC HRSN)10-item survey tool.
At workup and at Year 1
Fried Frailty
Time Frame: At Day 100 and at Year 1
Fried Frailty measured by percentage of patients meeting 3 or more of the diagnostic criteria for frailty.
At Day 100 and at Year 1
Quality of Life (PROMIS-29 Score)
Time Frame: At Day 100 and at Year 1
Quality of life as measured by Patient-Reported Outcome Measurement Information System-29 (PROMIS-29) score. The PROMIS-29 uses a scale of 1 to 5, with higher numbers representing a higher frequency, intensity, or duration.
At Day 100 and at Year 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Health
Time Frame: At Day 100 and at Year 1
Muscle health as assessed by MuscleSound, which quantifies changes in intramuscular adipose tissue (kg).
At Day 100 and at Year 1
Muscle Health
Time Frame: At Day 100 and at Year 1
Muscle health as assessed by MuscleSound, which quantifies changes in glycogen stores (g).
At Day 100 and at Year 1
Muscle Health
Time Frame: At Day 100 and at Year 1
Muscle health as assessed by MuscleSound, which quantifies changes in muscle wasting using the Skeletal Muscle Index (SMI), with a higher number representing greater muscle mass.
At Day 100 and at Year 1
Muscle Health
Time Frame: At Day 100 and at Year 1
Muscle health as assessed by MuscleSound, which quantifies changes in the presence or absence of sarcopenia.
At Day 100 and at Year 1
Accelerated Aging
Time Frame: At Year 1
Accelerated aging as measured by evaluation of blood biomarkers in plasma and peripheral blood mononuclear cells.
At Year 1
Home Food Bank Utilization
Time Frame: At Year 1
Home food bank utilization as measured by percentage of patients reporting use of food bank after intervention.
At Year 1
Impact of NOURISH on Reducing Healthcare Costs
Time Frame: At Year 1
Impact of NOURISH on all-cause medical resource use and associated costs as measured by the Functional Assessment of Chronic Illness Therapy-COST A FACIT Measure of Financial Toxicity (FACIT-COST) score. The FACIT-COST result scale ranges from a minimum of 0 to a maximum of 44, with a higher number representing better financial well-being.
At Year 1
Impact of NOURISH on Reducing Healthcare Costs
Time Frame: At Year 1
Impact of NOURISH on costs of resources to support the NOURISH intervention as measured by the study budget.
At Year 1
Impact of NOURISH on Reducing Healthcare Costs
Time Frame: At Year 1
Impact of NOURISH on preference-weighted measure of health status, as measured by the Euro Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L).
At Year 1
Impact on Participant Microbiome
Time Frame: At Year 1
Impact on participant microbiome as measured by 16S and/or shotgun sequencing.
At Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute of Nursing Research (NINR)
Duke University
Stanford University
Memorial Sloan-Kettering Cancer Center, USA

Investigators

  • Principal Investigator: Anthony Sung, MD, The University of Kansas Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NOURISH
  • R01NR021468 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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