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

Lung Cancer, Non-small Cell Clinical Trial

Official title:

NutriCare Intervention on Optimizing Nutritional Status, Reducing Treatment-Related Toxicities, and Improving Quality of Life Among Vulnerable Patients With Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04986670
• Other study ID #: STUDY00000203
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 299
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Adults (18+ years of age)

2. Newly diagnosed patients with lung cancer (non-small cell and small cell lung cancer):

• Patients with stages I-III lung cancer:

1) starting multimodality therapy including chemoradiation (either concurrent or sequential), systemic treatment, or radiation alone; and may be followed by surgery; or 2) starting adjuvant therapy after lung resection ((chemotherapy alone, radiation alone, or chemoradiation (either concurrent or sequential))

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer Metastatic
• Lung Cancer Recurrent
• Lung Cancer, Non-small Cell
• Lung Cancer, Small Cell
• Lung Neoplasms
• Nutritional Imbalance
• Small Cell Lung Carcinoma
• Treatment Side Effects

Intervention

Behavioral:
• Nutritional Counseling
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.

Other:
• Medically Tailored Meals (MTMs)
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.

Behavioral:
• Nutrition Prescription
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.

Other:
• Nutrition Assessment
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).

Behavioral:
• Nutrition Toolkit
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.
• Monthly Emails
Monthly emails will be sent to participants to encourage the use of the toolkit with healthy recipes and general nutrition information.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	The James Cancer Hospital	Columbus	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Tufts University	Fox Chase Cancer Center, M.D. Anderson Cancer Center, Ohio State University, Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program Implementation	(a) participation; (b) retention; (c) compliance	From consent through study completion, 6 months [for cohort 2] or 8 months [for cohort 1]
Primary	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)	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Primary	Weight	Change in weight and percent weight loss as measured in the clinic	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.
Secondary	Food Insecurity	Change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Secondary	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)	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Secondary	Patient-reported Functional Outcomes	Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by GAD-7	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Secondary	Patient-reported Functional Outcomes	Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by PHQ-9	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Secondary	Patient quality of life	Change in quality of life as assessed by EORTC-QLQ-30	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Secondary	Patient quality of life	Change in quality of life as assessed by EORTC-QLQ-LC13	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Secondary	Hospitalizations	Rate of hospitalizations will assessed by medical record review and linkage with discharge data	From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Secondary	ED visits	Rate of ED visits assessed by medical record review and linkage with discharge data	From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Secondary	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)	From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Secondary	Treatment Compliance	Treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist	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.
Secondary	Gut Microbial Composition	Change in gut microbiome via metagenomic whole shotgun sequencing (mWGS)	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Secondary	Cancer Mortality	National Death Index search performed approximately 5 years after the final patient is enrolled.	5-8 Years

External Links

•   NutriCare Study Website