About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Planning to receive transplant or cell therapy
"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
Disqualifiers
Patients who do not tolerate oral nutrition at the time of study enrollment
Trial design
Parallel
Treatments tested in this trial
Food Bags
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Peri-Transplant and Cell Therapy Malnutrition
Assessed by Global Leader Initiative on Malnutrition and confirmed by a dietitian
Secondary outcomes
Peri-TCT Incidence of Infections
Incidence and subtypes (blood stream, respiratory, or other) of infections captured as standard of care.
Peri-TCT Incidence of Acute Graft-vs-Host-Disease
Incidence of acute GVHD captured as standard of care.
Peri-TCT Incidence of Chronic Graft-vs-Host Disease
Incidence of chronic GVHD captured as standard of care.
Incidence of Relapse
Incidence of relapse captured as standard of care.
Other outcomes
Muscle Health
Muscle health as assessed by MuscleSound, which quantifies changes in intramuscular adipose tissue (kg).
Muscle Health
Muscle health as assessed by MuscleSound, which quantifies changes in glycogen stores (g).
Muscle Health
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.
Muscle Health
Muscle health as assessed by MuscleSound, which quantifies changes in the presence or absence of sarcopenia.
Sponsors and contacts
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University of Kansas Medical Center
Lead sponsor
Duke University
Collaborator
Stanford University
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
National Institute of Nursing Research (NINR)
Collaborator