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Medically Tailored Meals for Lung Cancer
N/A
Waitlist Available
Led By FangFang Zhang, MD, PhD
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-8 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well a nutrition intervention works in improving outcomes for patients with lung cancer who are economically disadvantaged, uninsured, racial and ethnic minorities, elderly, and/or rural residents.
Who is the study for?
The NutriCare trial is for vulnerable lung cancer patients who are economically disadvantaged, uninsured, belong to racial and ethnic minorities, elderly, or live in rural areas. They must be adults newly diagnosed with either small cell or non-small cell lung cancer and able to participate fully in the study.
What is being tested?
This study tests a combination of medically tailored meals and nutrition counseling designed to improve nutritional status, reduce side effects from treatment, and enhance quality of life among lung cancer patients. Participants will be divided into two groups receiving interventions for different durations (8 months or 6 months).
What are the potential side effects?
Since this trial focuses on nutrition rather than medication, there are no typical drug side effects. However, participants may experience changes in appetite or gastrointestinal discomfort as they adjust to new diets provided by the medically tailored meals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-8 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Nutritional Intake
Weight
Secondary study objectives
Cancer Mortality
ED visits
Food Insecurity
+7 moreOther study objectives
Program Implementation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NutriCareExperimental Treatment6 Interventions
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.
Group II: NutriToolActive Control2 Interventions
The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutritional Counseling
2016
Completed Phase 2
~560
Find a Location
Who is running the clinical trial?
Ohio State UniversityOTHER
866 Previous Clinical Trials
654,858 Total Patients Enrolled
Tufts Medical CenterOTHER
263 Previous Clinical Trials
264,169 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
3,063 Previous Clinical Trials
1,800,482 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are economically disadvantaged, from minority racial or ethnic groups, do not have health insurance, are elderly, or live in rural areas.You have health problems that affect how your body digests food or uses energy.You have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 3.You have recently been diagnosed with non-small cell or small cell lung cancer and meet certain treatment requirements.
Research Study Groups:
This trial has the following groups:- Group 1: NutriCare
- Group 2: NutriTool
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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