Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
210 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-04-30
Study Completion Date
2029-05-31
Brief Summary
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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.
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.
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Detailed Description
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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.
Conditions
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ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
Autologous Haemopoietic Stem Cell Transplant
CAR-T Cell Therapy
Food Insecurity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Information Group
These participants will receive information on their local food banks according to standard of care.
Group Type
NO_INTERVENTION
No interventions assigned to this group
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.
Group Type
EXPERIMENTAL
Food Bags
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
Other Intervention Names
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NOURISH
Eligibility Criteria
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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)
* 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
Minimum Eligible Age
8 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Duke University
OTHER
Sponsor Role
collaborator
Stanford University
OTHER
Sponsor Role
collaborator
Memorial Sloan-Kettering Cancer Center, USA
UNKNOWN
Sponsor Role
collaborator
National Institute of Nursing Research (NINR)
NIH
Sponsor Role
collaborator
University of Kansas Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Anthony Sung, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Kansas Cancer Center
Locations
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Stanford University
Stanford, California, United States
Site Status
NOT_YET_RECRUITING
University of Kansas Cancer Center
Fairway, Kansas, United States
Site Status
RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
NOT_YET_RECRUITING
Duke University
Durham, North Carolina, United States
Site Status
NOT_YET_RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Related Links
Access external resources that provide additional context or updates about the study.
https://health.gov/healthypeople/priority-areas/social-determinants-health/literature-summaries/food-insecurity
Healthy People 2030 - Food Insecurity
https://healthcare.rti.org/insights/food-insecurity-adult-health
The Impact Of Food Insecurity On Adult Health \& Well-Being
https://proof.utoronto.ca/food-insecurity/what-are-the-implications-of-food-insecurity-for-health-and-health-care/
What are the implications of food insecurity for health and health care?
https://www.feedingamerica.org/hunger-in-america/impact-of-hunger
Compromises and Coping Strategies 2014
https://frac.org/wp-content/uploads/hunger-health-impact-poverty-food-insecurity-health-well-being.pdf
The Impact of Poverty, Food Insecurity, and Poor Nutrition on Health and Well-Being
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NOURISH
Identifier Type: -
Identifier Source: org_study_id
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