Lifestyle Intervention of Food and Exercise for Lymphoma Survivors
LIFE-L
1 other identifier
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
January 30, 2026
January 1, 2026
3.5 years
March 31, 2023
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Survivors who participate
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.
Up to 12 months
Percentage of Participants Completing Intervention Sessions
Percentage of intervention session completion at the end of treatment will be assessed, using a threshold of greater than or equal to (\>=) 80-percent.
Up to 26 weeks (Post-Intervention)
Change in percentage of participant satisfaction
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.
4 weeks (post-intervention), up to 30 weeks
Secondary Outcomes (1)
Average Relative Dose Intensity (RDI)
Up to 30 weeks
Study Arms (2)
LIFE-L Group
EXPERIMENTALParticipants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.
Control Group
OTHERParticipants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy E Crane, Phd, RDN
University of Miami
- PRINCIPAL INVESTIGATOR
Craig Moskowitz, MD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 31, 2023
First Posted
May 3, 2023
Study Start
April 26, 2023
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share