Food as Medicine: An RCT to Study the Effect of Home Delivered, Medically Tailored Meals on Patients With Metastatic Cancer

NCT02887235 | Completed

• 1 other identifier: s15-00708
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of life measurement

  Quality of life will be assessed using the Functional Assessment in Cancer Therapy - General (FACT-G). Developed by Cella et al. the FACT-G is a well validated and widely used multi-dimensional health related quality of life measure for cancer patients. It consists of 28 self-assessment items on a 5 point Likert scale that address four domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. Scores are calculated for each sub-scale per FACT scoring instructions and summed for a total score ranging between 0 and 108 with higher scores indicating a higher quality of life.

  At 12 weeks follow up

Secondary Outcomes (5)

• Change in mood assessment

  From baseline to 12 weeks

• Patient weight assessment

  From baseline to 12 weeks

• Nutritional status assessment

  From baseline to 12 weeks

• Financial toxicity assessment

  From baseline to 12 weeks

• Food security assessment plus HDMTM from baseline to 12 weeks

  From baseline to 12 weeks

Study Arms (2)

Standard of Care (SOC) Meals

NO INTERVENTION

Patient assigned in this arm will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups.

Medically tailored meals

ACTIVE COMPARATOR

Patient assigned in this arm will receive home delivered, medically tailored meals (HDMTM) in addition to the standard nutritional care.

Other: Home Delivered, Medically Tailored Meals (HDTM)

Interventions

Home Delivered, Medically Tailored Meals (HDTM) OTHER

Medically tailored meals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Study Officials

• Peter Schiff, MD, PhD

  NYU Perlmutter Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: September 2, 2016
• Study Start: March 1, 2016
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

US (1)