Food as Medicine: An RCT to Study the Effect of Home Delivered, Medically Tailored Meals on Patients With Metastatic Cancer
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer.
Full description
The current standard of care at the cancer center is for all patients receiving cytotoxic therapy to undergo a nutritional consultation and evaluation with a registered oncology dietitian. The goal of this consultation is to prevent nutritional deficiencies, promote optimal nutritional intake, hydration, and weight maintenance, as well as maintain lean body mass.
All patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. However, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosis of pathologically confirmed metastatic pancreatic, hepatobiliary, esophageal, or lung cancer, either newly metastatic or metastatic at presentation (M1+) and enrollment within 6 weeks of diagnosis; measurable disease need not be present.
- Pain Score (PS) 0-3
- Age>18
- Both male and female subjects eligible
- All ethnicities eligible
- Access to refrigerator or freezer
Exclusion criteria
- Diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment
- Currently receiving home delivered meals from other sources
- Evidence of any alimentary tract obstruction or other condition preventing oral alimentation
- Requirement for enteral or parenteral nutrition at time of diagnosis
- Incarcerated individuals
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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