Nutrition OUtReach In Systems of Healthcare

Not Applicable

Recruiting

• Conditions: ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; Autologous Haemopoietic Stem Cell Transplant; CAR-T Cell Therapy; Food Insecurity

• Registration Number: NCT06802406
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-31
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Primary Completion: 2028-08
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peri-Transplant and Cell Therapy Malnutrition	Through Day 100	Assessed by Global Leader Initiative on Malnutrition and confirmed by a dietitian

Secondary Outcome Measures

Name	Time	Method
Social Determinants of Health	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.
Financial Toxicity	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.
Physical Function	At Day 100 and at Year 1	Physical function measured by average 6 minute walk test distance.
Cognitive Function	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.
Peri-TCT Incidence of Infections	Through Day 100	Incidence and subtypes (blood stream, respiratory, or other) of infections captured as standard of care.
Peri-TCT Incidence of Acute Graft-vs-Host-Disease	Through Day 180	Incidence of acute GVHD captured as standard of care.
Peri-TCT Incidence of Chronic Graft-vs-Host Disease	Through Year 1	Incidence of chronic GVHD captured as standard of care.
Incidence of Relapse	Through Year 1	Incidence of relapse captured as standard of care.
Incidence of Treatment-Related Mortality	Through End of Study	Incidence of treatment-related mortality captured as standard of care.
Overall Survival	Through Year 1	Overall survival captured as standard of care.
Quality of Life (PROMIS-29 Score)	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.
Mental Health	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.
Dietary Habits and Consumption	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.
Impact on Food Insecurity	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.
Fried Frailty	At Day 100 and at Year 1	Fried Frailty measured by percentage of patients meeting 3 or more of the diagnostic criteria for frailty.

Trial Locations

Locations (4)

Stanford University; 🇺🇸 Stanford, California, United States

University of Kansas Cancer Center; 🇺🇸 Fairway, Kansas, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States