Clinical trial NCT04986670: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Fox Chase Cancer Center
name: M.D. Anderson Cancer Center
name: Ohio State University
name: Tufts Medical Center
First posted: 2021-08-03
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Nutritional Intake
timeFrame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
measure: Weight
timeFrame: 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 outcomes:
measure: Food Insecurity
timeFrame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
measure: Patient-reported Symptoms
timeFrame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
measure: Patient-reported Functional Outcomes
timeFrame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
measure: Patient-reported Functional Outcomes
timeFrame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
measure: Patient quality of life
timeFrame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
measure: Patient quality of life
timeFrame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
measure: Hospitalizations
timeFrame: From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
measure: ED visits
timeFrame: From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
measure: Treatment-related Toxicities
timeFrame: From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
measure: Treatment Compliance
timeFrame: 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.
measure: Gut Microbial Composition
timeFrame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
measure: Cancer Mortality
timeFrame: 5-8 Years
Other outcomes:
measure: Program Implementation
timeFrame: From consent through study completion, 6 months [for cohort 2] or 8 months [for cohort 1]
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Columbus
country: United States
facility: The James Cancer Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Tufts University
name: FangFang Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Colleen Spees, PhD, MEd, RD, LD, FAND
role: PRINCIPAL_INVESTIGATOR
References: