Colorectal Cancer (Diagnosis)
Conditions
Keywords
colorectal cancer, medically tailored meals, ultra processed foods, survival, health outcomes
Brief summary
This research study is a three-arm, parallel-group randomized clinical trial that examines the feasibility and initial impact of consuming medically tailored meals to reduce intake of ultra-processed food and improve health and survival outcomes among 60 patients with stage I-III colorectal cancer.
Detailed description
This research study is exploring whether medically tailored meals can help survivors with stage I-III colorectal cancer reduce their intake of ultra-processed foods and improve their health. Ultra-processed foods, such as packaged snacks, fast food, and sugary drinks, make up a large portion of many Americans' diets and have been linked to a higher risk of colorectal cancer and poorer survival. While experts recommend limiting these foods, many patients face challenges like limited time, cooking skills, or access to healthy options, making dietary changes difficult. Medically tailored meals, designed by dietitians to meet specific health needs, may offer a practical solution by making healthy eating easier and more accessible. This study will evaluate whether these meals, with or without fresh produce, can improve diet quality, support healthier gut bacteria, and reduce inflammation. Researchers will measure changes in gut health and blood markers before and after the program to better understand how diet can influence recovery and long-term outcomes for colorectal cancer survivors. This research study will last about 3 years. It includes a 2-week preparation period, a 6-week intervention with a medically tailored meals (MTM) program, 2 clinic visits (one prior to starting and one following the 6-week intervention period), 2 nutrition counseling visits with a registered dietitian (also conducted before and after the intervention), and follow-up contacts (4 weeks after the final visit and then every year for 3 years). Because it is unknown which meal plan is best, participants will be randomized to one of these 3 meal plan groups: * MTM: participants will receive 3 fully prepared, home-delivered, medically tailored meals per day for 6 weeks. * MTM plus Fresh Produce: participants will receive 2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks. * Control group: participants will receive weekly recipes and meal-planning materials only; no food will be provided.
Interventions
BEHAVIORALMTM: Medically tailored meals
3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
BEHAVIORALMTM plus Fresh Produce
2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
BEHAVIORALControl group
weekly recipes and meal-planning materials only; no food will be provided.
Sponsors
Massachusetts General Hospital
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy, and radiotherapy) at least 2 months ago. * Age ≥18 years. * ECOG = 0 or 1 * Participants must have a high intake of UPFs, defined as meeting at least three of the following criteria, each consumed on more than or equal to 3 days per week: * Ready-to-eat or ready-to-heat dishes, such as packaged frozen meals, prepared entrées, quick dishes, or microwaveable packaged foods; * Sugar- or artificially sweetened beverages (e.g., soda, diet coke, sweetened teas, bubble tea, flavored instant coffee mixes), alcoholic beverages, or other commercially prepared sweetened drinks; * Packaged snack foods, such as chips, cookies, ice cream, desserts, or other commercially prepared snack items; * Frequent fast-food consumption, including meals or beverages purchased from fast-food or quick-service restaurants, such as McDonald's, Wendy's, KFC, Burger King, Five Guys, Chick-fil-A, Dairy Queen, etc. * Home-cooked meals that rely primarily on pre-prepared ingredients, such as deli meats, canned fish, canned fruits and vegetables, frozen foods or ingredients, or similar products used more often than fresh produce, raw meat/seafood, or raw fruits and vegetables. * Subjects must be able and willing to follow study procedures and instructions. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Participants who are receiving any other investigational agents or lifestyle/dietary interventions. * Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol. * Any prior diagnosis of invasive (i.e., excluding intramucosal cancer) gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (except non-melanoma skin) in which there has been any active treatment within the last three years. * Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment. * Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection. * Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results. * Participants who are pregnant Participants who may become pregnant or partners of those who may become pregnant while on study will receive contraception counseling. Participants or partners of those who become pregnant while participating in the study should immediately inform their doctor. * Participants who are unwilling to make dietary changes. * Individuals who do not have access to or are not able to participate in remote nutrition counseling and assessment sessions via Zoom or phone calls.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of feasibility of consuming medically tailored meals through study participation | From enrollment to the end of study, assessed at year 3 follow-up | Feasibility will be assessed by the following metrics: • percentage of eligible patients who enroll |
| Evaluation of feasibility of consuming medically tailored meals through retention | From enrollment to the end of study, assessed at year 3 follow-up | Feasibility will be assessed by the following metrics: • percentage of enrolled participants who complete study visits and outcome assessments |
| Evaluation of feasibility of consuming medically tailored meals through compliance | From enrollment to the final visit at 8 weeks | Feasibility will be assessed by the following metrics: • proportion of participants who adhere to assigned interventions, defined as consumption of provided meals and/or produce (for intervention arms), completion of at least two dietary assessments, and provision of blood, tumor tissue, and fecal samples at baseline and end of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MTM Impact on Diet | From enrollment to the end of study, assessed at year 3 follow-up | The extent to which the MTM-based intervention improves dietary intake and food insecurity across study arms |
| MTM Impact on Patient Outcomes | From enrollment to the end of study, assessed at year 3 follow-up | The extent to which the MTM-based intervention improves quality of life and patient-reported outcomes across study arms |
| Relative Composition of Gut Microbiome Features | From enrollment to the final visit at 8 weeks | Comparing change in gut microbiome features (species - to strain level specificity; metabolic pathways; enzymes) using deep meta'omic profiling in pre- and post- treatment samples. |
| Relative Composition of Gut Metabolites | From enrollment to the final visit at 8 weeks | Comparing change in gut metabolites using deep meta'omic profiling in pre- and post- treatment samples. |
| Change in Stool Metabolomics | From enrollment to the final visit at 8 weeks | Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile. |
| Change in Plasma Metabolomics | From enrollment to the final visit at 8 weeks | Comparing change in plasma metabolomics, using non-targeted global metabolomics analysis on blood samples to examine intensity changes in the blood metabolite profile. |
| Longitudinal Biomarker Changes | From enrollment to the end of study, assessed at year 3 follow-up | Changes in clinical biomarkers using EHR data. |
| Longitudinal Disease Progression Changes | From enrollment to the end of study, assessed at year 3 follow-up | Changes in disease progression outcomes using EHR data. |
Countries
United States
Contacts
CONTACTMengxi Du, RD, PhD, MPH
PRINCIPAL_INVESTIGATORMengxi Du, RD, PhD, MPH
Massachusetts General Hospital
Outcome results
None listed