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NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer

Primary Purpose

Lung Cancer, Small Cell, Lung Cancer Metastatic, Lung Cancer Recurrent

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional Counseling
Medically Tailored Meals (MTMs)
Nutrition Prescription
Nutrition Assessment
Nutrition Toolkit
Monthly Emails
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer, Small Cell focused on measuring lung cancer, malnutrition, vulnerability, medically tailored meals, nutrition counseling

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults (18+ years of age)
  2. Newly diagnosed patients with lung cancer (non-small cell and small cell lung cancer):

    o Patients with stages I-III lung cancer: Eligible at diagnosis for up to 6 weeks after: 1) starting multimodality therapy with combination chemoradiation or chemoradiation followed by surgery; or 2) starting adjuvant therapy after lung resection (chemotherapy alone or chemotherapy followed by radiation therapy)

    o Patients with stage IV lung cancer or recurrent/metastatic: Eligible at diagnosis and for up to 3 months after starting treatment

    o Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-3

  3. Vulnerable patients who meet at least one of the following criteria:

    • Economically disadvantaged (household gross monthly income at or below 130% of the Federal Poverty Level)
    • Racial and ethnic minorities (African Americans, American Indians and Alaska Natives, Asians and Pacific Islanders, and Hispanics)
    • No health insurance
    • Elderly patients (ages 65 years or older)
    • Reside in rural areas (non-metropolitan counties with less than 50,000 people)
  4. Voluntarily provide consent, HIPPA authorization form, and consent from treating oncologist.
  5. Able to speak and read English themselves or with minimal help.
  6. Able to receive medically-tailored meals for the course of the study if being assigned to the intervention arm, and willing to sign the MTM agreement.

Exclusion Criteria:

  1. Cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program.
  2. Have medical conditions that significantly impact digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon; pancreas dysfunction; brain surgery that alters cognition; severe food allergies; etc.) or have active metabolic or digestive illnesses (i.e., Celiac disease, IBS, renal insufficiency, hepatic insufficiency).
  3. Pregnant or planning to become pregnant during the study.
  4. Unable to receive medically-tailored meals for the course of the study if being assigned to the intervention arm, including lack of a permanent address to which meals can be delivered (a friend or home address is acceptable given it is used on a consistent basis), not having a fully functioning kitchen with a microwave or oven for cooking, not having a standard-sized refrigerator with a freezer with storage capacity to hold one week's worth of meals; or unwilling to sign the MTM agreement.

Sites / Locations

  • Tufts Medical Center
  • The James Cancer HospitalRecruiting
  • Fox Chase Cancer Center
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NutriCare

NutriTool

Arm Description

The oncology care team will provide participants with nutrition toolkit involving printed educational materials, a nutrition prescription, referral to registered dietitians (RDs) for remotely-delivered medical nutrition therapy counseling, and home-delivery of medically tailored meals.

The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.

Outcomes

Primary Outcome Measures

Nutritional Intake
Change in diet quality and intake of key food groups and nutrients as assessed by the National Cancer Institute Diet History Questionnaire (DHQ III)
Weight
Change in weight and percent weight loss as measured in the clinic
Treatment Compliance
Treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist
Treatment-related Toxicities
Rate of treatment-related toxicities assessed by the treating medical oncologist using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)
Hospitalizations
Rate of hospitalizations will assessed by medical record review and linkage with discharge data
ED visits
Rate of ED visits assessed by medical record review and linkage with discharge data
Patient-reported Symptoms
Change in patient-reported symptoms (fatigue, pain, nausea, vomiting, appetite loss, and sleep disturbance) as assessed by a Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE)
Patient quality of life
Change in quality of life as assessed by EORTC-QLQ-30
Patient quality of life
Change in quality of life as assessed by EORTC-QLQ-LC13
Patient-reported Functional Outcomes
Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by GAD-7
Patient-reported Functional Outcomes
Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by PHQ-9

Secondary Outcome Measures

Food Insecurity
Change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey
Gut Microbial Composition
Change in gut microbiome via metagenomic whole shotgun sequencing (mWGS)
Cancer Mortality
National Death Index search performed approximately 5 years after the final patient is enrolled.

Full Information

First Posted
July 13, 2021
Last Updated
June 1, 2023
Sponsor
Tufts University
Collaborators
Fox Chase Cancer Center, M.D. Anderson Cancer Center, Ohio State University, Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04986670
Brief Title
NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer
Official Title
NutriCare Intervention on Optimizing Nutritional Status, Reducing Treatment-Related Toxicities, and Improving Quality of Life Among Vulnerable Patients With Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Fox Chase Cancer Center, M.D. Anderson Cancer Center, Ohio State University, Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The NutriCare study aims to develop, implement, and evaluate the efficacy of an innovative intervention strategy (medically tailored meals plus nutrition counseling) to integrate nutrition into the standard of care for oncology to improve outcomes of vulnerable patients with lung cancer. The NutriCare study evaluates the efficacy of the intervention on optimizing nutritional status, reducing treatment-related toxicities, and improving the quality of life of patients with lung cancer who are economically disadvantaged, uninsured, racial and ethnic minorities, elderly, and/or rural residents from four major medical centers in diverse regions of the United States (U.S.). There will be two cohorts for NutriCare with cohort 1 recruiting 150 patients completing an 8-month intervention and cohort 2 recruiting 120 patients completing a 6-month intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Small Cell, Lung Cancer Metastatic, Lung Cancer Recurrent, Treatment Side Effects, Lung Cancer, Non-small Cell, Nutritional Imbalance
Keywords
lung cancer, malnutrition, vulnerability, medically tailored meals, nutrition counseling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For the proposed study, we will randomize participants into two groups at a 1:1 ratio to an intervention or an enhanced control group. For participants randomized to the enhanced control group, the NutriTool, the oncology care team will provide participants with a nutrition toolkit involving printed educational materials. For participants randomized to the intervention group, the NutriCare, the oncology care team will additionally provide participants with home-delivery of medically tailored meals and referral to registered dietitians (RDs) for remotely-delivered nutrition counseling.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NutriCare
Arm Type
Experimental
Arm Description
The oncology care team will provide participants with nutrition toolkit involving printed educational materials, a nutrition prescription, referral to registered dietitians (RDs) for remotely-delivered medical nutrition therapy counseling, and home-delivery of medically tailored meals.
Arm Title
NutriTool
Arm Type
Active Comparator
Arm Description
The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Counseling
Intervention Description
Medical oncology providers will refer participants to oncology RDs for remotely delivered medical nutrition therapy counseling. For cohort 1, participants will receive nutrition counseling for 8 months. The counseling will be provided on a weekly basis during the first 6 months and every other week during the last 2 months (for cohort 1 only). For cohort 2, participants will receive nutrition counseling for 6 months. The ultimate frequency of nutrition counseling being provided to each participant will also be adjusted according to the participant's preference and needs.
Intervention Type
Other
Intervention Name(s)
Medically Tailored Meals (MTMs)
Intervention Description
Medically tailored meals will be provided to participants in the intervention group for a total of 24 weeks for both cohorts. During the first 8 weeks of the intervention, 3 meals/day will be provided each week for a total of 168 meals per participant. It will be followed by less frequent meal provision during the subsequent 16 weeks following this schedule: 3 meals/day will be provided every other week for the next 8 weeks (a total of 84 meals per participant); and 3 meals/day will be provided every four weeks during the last 8 weeks (a total of 42 meals per participant). The number of meals provided to each participant may be adjusted according to participant's preference and needs.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Prescription
Intervention Description
Oncology providers will advise participants with lung cancer to follow evidence-based nutrition recommendations using a Nutrition Prescription. The Nutrition Prescription aims to enhance providers' role in communicating basic nutrition advice to participants with lung cancer. It contains seven recommendations, adapted from the newly released Cancer Prevention Recommendations by WCRF/AICR with strong evidence-base.
Intervention Type
Other
Intervention Name(s)
Nutrition Assessment
Intervention Description
Oncology care providers will assess the nutritional status of patients with lung cancer using PG-SGA Short Form (the Scored Patient-Generated Subjective Global Assessment). PG-SGA is an interdisciplinary patient assessment in oncology and other chronic catabolic conditions. The short form contains four patient generated historical components (weight history, food intake symptoms, and activities and function).
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Toolkit
Intervention Description
Patients will receive a printed copy of a Nutrition Toolkit from providers. Evidence-based nutrition recommendations have been compiled for cancer survivors from 4 sources into a Nutrition Toolkit. The sources include: (1) AmericanCancer Society (ACS) Nutrition and Physical Activity Guidelines for Cancer Survivors; (2)World Cancer Research Fund / American Institute for Cancer Research (WFRF/AICR) Cancer Nutrition Guide; (3) National Cancer Institute (NCI) Eating Hints; and (4) National Comprehensive Cancer Network (NCCN) Guidelines for Cancer Survivors. The Nutrition Toolkit outlines topics about the impact of cancer treatment on dietary intake patterns and quality, strategies to manage treatment-related eating issues, maintaining a healthy weight post treatment, and evidence-based recommendations and practical. Nutrition Toolkit strategies for improving diet quality and maintaining an optimal weight for cancer survivors.
Intervention Type
Behavioral
Intervention Name(s)
Monthly Emails
Intervention Description
Monthly emails will be sent to participants to encourage the use of the toolkit with healthy recipes and general nutrition information.
Primary Outcome Measure Information:
Title
Nutritional Intake
Description
Change in diet quality and intake of key food groups and nutrients as assessed by the National Cancer Institute Diet History Questionnaire (DHQ III)
Time Frame
Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Title
Weight
Description
Change in weight and percent weight loss as measured in the clinic
Time Frame
Recorded at each clinical visit. From date of beginning baseline until the date of completing the final (6 or 8 month) study visit, an average of 3-4 clinic visits dependent on course of treatment.
Title
Treatment Compliance
Description
Treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist
Time Frame
Recorded at each clinical visit. From date of beginning baseline until the date of completing the final (6 or 8 month) study visit, an average of 3-4 clinic visits dependent on course of treatment.
Title
Treatment-related Toxicities
Description
Rate of treatment-related toxicities assessed by the treating medical oncologist using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)
Time Frame
From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Title
Hospitalizations
Description
Rate of hospitalizations will assessed by medical record review and linkage with discharge data
Time Frame
From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Title
ED visits
Description
Rate of ED visits assessed by medical record review and linkage with discharge data
Time Frame
From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Title
Patient-reported Symptoms
Description
Change in patient-reported symptoms (fatigue, pain, nausea, vomiting, appetite loss, and sleep disturbance) as assessed by a Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE)
Time Frame
Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Title
Patient quality of life
Description
Change in quality of life as assessed by EORTC-QLQ-30
Time Frame
Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Title
Patient quality of life
Description
Change in quality of life as assessed by EORTC-QLQ-LC13
Time Frame
Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Title
Patient-reported Functional Outcomes
Description
Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by GAD-7
Time Frame
Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Title
Patient-reported Functional Outcomes
Description
Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by PHQ-9
Time Frame
Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Secondary Outcome Measure Information:
Title
Food Insecurity
Description
Change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey
Time Frame
Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Title
Gut Microbial Composition
Description
Change in gut microbiome via metagenomic whole shotgun sequencing (mWGS)
Time Frame
Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Title
Cancer Mortality
Description
National Death Index search performed approximately 5 years after the final patient is enrolled.
Time Frame
5-8 Years
Other Pre-specified Outcome Measures:
Title
Program Implementation
Description
(a) participation; (b) retention; (c) compliance
Time Frame
From consent through study completion, 6 months [for cohort 2] or 8 months [for cohort 1]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (18+ years of age) Newly diagnosed patients with lung cancer (non-small cell and small cell lung cancer): o Patients with stages I-III lung cancer: Eligible at diagnosis for up to 6 weeks after: 1) starting multimodality therapy with combination chemoradiation or chemoradiation followed by surgery; or 2) starting adjuvant therapy after lung resection (chemotherapy alone or chemotherapy followed by radiation therapy) o Patients with stage IV lung cancer or recurrent/metastatic: Eligible at diagnosis and for up to 3 months after starting treatment o Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-3 Vulnerable patients who meet at least one of the following criteria: Economically disadvantaged (household gross monthly income at or below 130% of the Federal Poverty Level) Racial and ethnic minorities (African Americans, American Indians and Alaska Natives, Asians and Pacific Islanders, and Hispanics) No health insurance Elderly patients (ages 65 years or older) Reside in rural areas (non-metropolitan counties with less than 50,000 people) Voluntarily provide consent, HIPPA authorization form, and consent from treating oncologist. Able to speak and read English themselves or with minimal help. Able to receive medically-tailored meals for the course of the study if being assigned to the intervention arm, and willing to sign the MTM agreement. Exclusion Criteria: Cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program. Have medical conditions that significantly impact digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon; pancreas dysfunction; brain surgery that alters cognition; severe food allergies; etc.) or have active metabolic or digestive illnesses (i.e., Celiac disease, IBS, renal insufficiency, hepatic insufficiency). Pregnant or planning to become pregnant during the study. Unable to receive medically-tailored meals for the course of the study if being assigned to the intervention arm, including lack of a permanent address to which meals can be delivered (a friend or home address is acceptable given it is used on a consistent basis), not having a fully functioning kitchen with a microwave or oven for cooking, not having a standard-sized refrigerator with a freezer with storage capacity to hold one week's worth of meals; or unwilling to sign the MTM agreement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Fang Zhang, MD,PhD
Phone
6176363706
Email
Fang_Fang.zhang@tufts.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Cohen, MS,RD
Email
mary_kathryn.cohen@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FangFang Zhang, MD, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Colleen Spees, PhD, MEd, RD, LD, FAND
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Completed
Facility Name
The James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Presley, MD
Phone
614-293-6453
Email
carolyn.presley@osumc.edu
First Name & Middle Initial & Last Name & Degree
Carolyn Presley, MD
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joya Chandra, PhD
Phone
713-563-5405
Email
jchandra@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Joya Chandra, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://food-price.org/nutricare
Description
NutriCare Study Website

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NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer

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