Medically Tailored Meals to Reduce Ultra-processed Food Intake in Colorectal Cancer Survivors
A Pilot Medically Tailored Meal-Based Intervention to Reduce Ultra-processed Food Intake Among Patients With Stages I-III Colorectal Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether meals made for a person's medical needs can help reduce highly processed foods and improve health and survival. It is for 60 adults with stage I–III colon or rectal cancer who have finished standard treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have stage I, II, or III colon or rectal adenocarcinoma, a type of cancer confirmed by a tissue test.
- Have finished standard cancer treatment at least 2 months ago.
- Be fully active or able to walk and do light work, even if hard physical activity is limited.
- Eat or drink at least 3 of these groups on 3 or more days each week: packaged ready-made meals; sweetened or alcoholic drinks; packaged snacks; fast food; or home meals using mostly prepared, canned, or frozen ingredients instead of fresh foods.
- Be able and willing to follow the study steps and instructions.
- Be able to understand and willing to sign a form agreeing to join the study.
Who can't join
- You are receiving other experimental treatments, lifestyle or diet programs, or other cancer treatment.
- You have a past diagnosis of cancer that grew beyond the inner lining of the digestive tract, or another cancer treated within the past 3 years, except non-melanoma skin cancer.
- You have another cancer at the same time and are receiving treatment for it.
- You have a known positive test for HIV, hepatitis C, or a current short-term or long-term hepatitis B infection.
- You have an uncontrolled illness, such as an infection or serious heart problem, or mental health or social problems that the study doctor thinks could make the study unsafe or affect participation or results.
- You are pregnant.
- You are not willing to change your diet.
- You cannot access or take part in nutrition counseling and check-ins by Zoom or phone.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
MA
- Massachusetts General Hospital · Boston, MA 02114Mengxi Du, RD, PhD, MPH · Study contact · 617-726-5405 · mdu1@mgh.harvard.eduMengxi Du, RD, PhD, MPH · Principal investigatorMore trials in Boston