A Pilot Medically Tailored Meal-Based Intervention to Reduce Ultra-processed Food Intake Among Patients With Stages I-III Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of feasibility of consuming medically tailored meals through study participation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Medically Tailored Meals (MTM)
3 prepared meals per day (i.e., breakfast, lunch, and dinner) for a total of 126 meals.
干预措施: MTM: Medically tailored meals (Behavioral)
Medically Tailored Melas (MTM) plus Fresh Produce
2 prepared meals per day (84 meals total), plus weekly fresh produce and recipes to help prepare a third meal each day.
干预措施: MTM plus Fresh Produce (Behavioral)
Control group
weekly meal planning materials and recipes only; no food will be provided.
干预措施: Control group (Behavioral)
结局指标
主要结局
Evaluation of feasibility of consuming medically tailored meals through study participation
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Longitudinal Disease Progression Changes(From enrollment to the end of study, assessed at year 3 follow-up)
- Longitudinal Biomarker Changes(From enrollment to the end of study, assessed at year 3 follow-up)
- MTM Impact on Diet(From enrollment to the end of study, assessed at year 3 follow-up)
- MTM Impact on Patient Outcomes(From enrollment to the end of study, assessed at year 3 follow-up)
- Relative Composition of Gut Microbiome Features(From enrollment to the final visit at 8 weeks)
- Relative Composition of Gut Metabolites(From enrollment to the final visit at 8 weeks)
- Change in Stool Metabolomics(From enrollment to the final visit at 8 weeks)
- Change in Plasma Metabolomics(From enrollment to the final visit at 8 weeks)
研究者
Mengxi Du
Principal Investigator
Massachusetts General Hospital