NCT05839210 · University of Miami
Lifestyle Intervention of Food and Exercise for Lymphoma Survivors
(LIFE-L)
What this study is about
The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.
View original scientific description
The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.
Interventions
BEHAVIORAL
LIFE-L Mediterranean Diet
Mediterranean Diet will include goals of: 4+ vegetable servings (2-4 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week. Limit or avoid highly processed foods, sugar-sweetened beverages and foods, processed meats, red meat, and alcohol.
BEHAVIORAL
LIFE-L Home-Based Exercise Program
The Home-Based Exercise Program will include goals of: 150+ minutes moderate or 75+ minutes vigorous exercise per week, completed in sessions of at least 10-minute duration, including daily aerobic exercise plus two resistance-based exercise sessions per week.
BEHAVIORAL
Supportive Materials
Participants will receive an informational study notebook, an exercise reference poster and videos, a Fitbit, and three stretch bands of different intensities. Participants will also receive supportive and informational text messages or emails three (3) times per week during the study; participants can opt-out of these messages. Participants will be requested to utilize the Fitbit app to track exercise sessions, as well as the MyFitnessPal app to track their diet. Support to set up apps will be provided by research staff. For participants who choose not to use the app, a laminated diet and exercise tracking sheet with dry erase marker will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to research staff each week.
Primary outcome measures
Percentage of Survivors who participate
Time frame: Up to 12 months
Percentage of survivors who agree to participate out of the total number of participants recruited will be assessed using a threshold of greater than or equal to (\>=) 50-percent.
Percentage of Participants Completing Intervention Sessions
Time frame: Up to 26 weeks (Post-Intervention)
Percentage of intervention session completion at the end of treatment will be assessed, using a threshold of greater than or equal to (\>=) 80-percent.
Change in percentage of participant satisfaction
Time frame: 4 weeks (post-intervention), up to 30 weeks
The change in percentage of participant satisfaction rate at the end of study participation will be assessed, using a threshold of greater than or equal to (\>=) 80-percent. Participant satisfaction will be assessed via exit interviews.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years of age or older
- Any sex/gender
- Able to provide consent
- Able to read or understand English or Spanish
- Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring at least 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:
- R-CHOP or R-CHOP-like regimen
- BV-AVD or ABVD or checkpoint inhibitor+AVD
- ECOG Performance Status grade of \<2 a. PI approval needed if ECOG = 2
- Approval from treating oncologist, confirmed via email or in writing
- Delivery of chemotherapy treatments at one of the following institutions:
- Sylvester Comprehensive Cancer Center (including satellite/network sites)
- University of Miami Hospital/UHealth Tower
- Internet access on a smart phone, tablet, or computer
- Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.
Exclusion criteria
- Individuals younger than 18 years of age
- Unable to provide consent
- Unable to read or understand English or Spanish
- Any contraindication for diet change or exercising as determined by physician
- Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
- Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month
- History of dementia or major psychiatric disease
- History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
Where
- Miami, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations