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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-08-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of Care (SOC) Meals

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Medically tailored meals

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

Group Type ACTIVE_COMPARATOR

Home Delivered, Medically Tailored Meals (HDTM)

Intervention Type OTHER

Interventions

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Home Delivered, Medically Tailored Meals (HDTM)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No