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.
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
Ready-to-eat or ready-to-heat dishes, such as packaged frozen meals, prepared entrées, quick dishes, or microwaveable packaged foods;
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.
Parallel
MTM: Medically tailored meals
Behavioral3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
MTM plus Fresh Produce
Behavioral2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
Control group
Behavioralweekly recipes and meal-planning materials only; no food will be provided.
Evaluation of feasibility of consuming medically tailored meals through study participation
Feasibility will be assessed by the following metrics: • percentage of eligible patients who enroll
Evaluation of feasibility of consuming medically tailored meals through retention
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
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
MTM Impact on Diet
The extent to which the MTM-based intervention improves dietary intake and food insecurity across study arms
MTM Impact on Patient Outcomes
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
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
Comparing change in gut metabolites using deep meta'omic profiling in pre- and post- treatment samples.
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Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
