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

Quality of Life Clinical Trial

Official title:

Food as Medicine: A Phase III Randomized Controlled Trial of Home Delivered, Medically Tailored Meals (HDMTM) on Quality of Life in Metastatic Lung and Non-colorectal GI Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887235
• Other study ID #: s15-00708
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 8, 2019

Study information

• Verified date: June 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

Other:
• Home Delivered, Medically Tailored Meals (HDTM)

Locations

Country	Name	City	State
United States	NYU Perlmutter Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in mood assessment	The Hospital Anxiety Depression Survey will be utilized to assess patient mood on this study. It is a validated, 14 item self-assessment tool used to assess severity of anxiety and depression symptoms in patients. Two 7 item subscales assess anxiety and depression in the past one week. Item responses are integer values between 0-3 and values for each subscale are added to give a subscale score. Scores on each subscale can range from 0 to 21 and a score greater than 11 is considered consistent with anxiety or depression. Scores of 7 or less are considered normal and scores of 8 to 10 are borderline. A score of 8 or greater on the anxiety subscale has a sensitivity of 0.9 and specificity of 0.78 for anxiety. Similarly, a score of 8 or greater on the depression subscale has a sensitivity of 0.83 and specificity of 0.79 for depression.	From baseline to 12 weeks
Secondary	Patient weight assessment	Weight is measured at each physician visit per hospital policy. Weight at each interval will be recorded in the electronic medical record (EMR). Should the patient not have a scheduled visit with their primary oncologist or registered dietitian within the required visit window, any weight recorded in the EMR within the visit window can be used. The changes in weight from baseline to 12 weeks,will be measured using the Abridged Patient Generated Subjective Global Assessment (abPG-SGA) in the 2 arms.	From baseline to 12 weeks
Secondary	Nutritional status assessment	The change in nutritional status from baseline will be measured using the Abridged Patient Generated Subjective Global Assessment (abPG-SGA) in the 2 arms.	From baseline to 12 weeks
Secondary	Financial toxicity assessment	In 2014 a novel instrument to assess subjective financial toxicity, the Financial Toxicity Patient-Reported Outcome in Cancer measure (COST) was designed and recently validated. It is an 11 item assessment with 5 point Likert scale responses developed by de Souza et al reference to assess the levels of financial distress experienced by cancer patients. Each item response is scored 0-4 and then all individual item scores are summed. For incomplete surveys, the sum score is multiplied by 11 and then divided by the number of items answered. Total scores can range from 0-44 with higher scores representing higher subjective patient financial toxicity.	From baseline to 12 weeks
Secondary	Food security assessment plus HDMTM from baseline to 12 weeks	U.S. Adult Food Security Survey module to assess food security.It is a 10 item questionnaire developed by the US Department of Agriculture to specifically assess food insecurity in adults. Affirmative responses to each item are given one point. Total raw scores are calculated by adding all points (affirmative responses) and can range from 0-10. A raw score of zero is considered high food security. A raw score 1-2 is considered marginal food security. A raw score 3-5 is considered low food security and raw scores 6-10 are very low food security.	From baseline to 12 weeks