This randomized phase III trial studies how well home delivered, medically tailored meals work in improving quality of life in patients with pancreatic, esophageal, liver, or lung cancer that has spread to other places in the body. Home delivered, medically tailored meals may improve nutrition and quality of life in patients with pancreatic, esophageal, liver, or lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02887235.
PRIMARY OBJECTIVES:
I. To compare the effect of standard of care (SoC) versus standard of care with home delivered, medically tailored meals (HDMTM) on quality of life in metastatic lung and non-colorectal gastrointestinal (GI) cancer patients at 12 weeks follow-up.
SECONDARY OBJECTIVES:
I. Compare the change in patient weight and nutritional status between patients receiving SoC and SoC plus HDMTM from baseline to 12 weeks.
II. Compare the change in patient mood between patients receiving SoC and SoC plus HDMTM at from baseline to 12 weeks.
III. Compare the change in patient reported financial toxicity between patients receiving SoC and SoC plus HDMTM from baseline to 12 weeks.
IV. Compare the change in food security between patients receiving SoC and SoC plus HDMTM from baseline to 12 weeks.
TERTIARY OBJECTIVES:
I. Compare the effect of SoC versus SoC plus HDMTM on survival.
II. Compare the difference in healthcare utilization between patients receiving SoC versus SoC plus HDMTM at 12 weeks.
III. Assess cost-effectiveness of HDMTM at 12 weeks.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups.
ARM II: Patients receive standard of care nutritional services as in Arm I. Patients also receive 21 home delivered, medically tailored meals per week for up to 1 year.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorPeter B. Schiff