Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE-L)

January 28, 2026 updated by: Tracy E Crane, PhD, RDN, University of Miami

Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Craig Moskowitz, MD
        • Contact:
        • Principal Investigator:
          • Tracy E Crane, PhD, RDN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. Any sex/gender
  3. Able to provide consent
  4. Able to read or understand English or Spanish

  5. 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:

    1. R-CHOP or R-CHOP-like regimen
    2. BR
    3. BV-AVD or ABVD or checkpoint inhibitor+AVD

  6. ECOG Performance Status grade of <2

    a. PI approval needed if ECOG = 2

  7. Approval from treating oncologist, confirmed via email or in writing

  8. Delivery of chemotherapy treatments at one of the following institutions:

    1. Sylvester Comprehensive Cancer Center (including satellite/network sites)
    2. University of Miami Hospital/UHealth Tower
  9. Internet access on a smart phone, tablet, or computer
  10. Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.

Exclusion Criteria:

  1. Individuals younger than 18 years of age
  2. Unable to provide consent
  3. Unable to read or understand English or Spanish
  4. Any contraindication for diet change or exercising as determined by physician
  5. Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
  6. Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
  7. History of dementia or major psychiatric disease
  8. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFE-L Group
Participants 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.
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.
Other: Control Group
Participants 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months
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.
Up to 26 weeks (Post-Intervention)
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.
4 weeks (post-intervention), up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Relative Dose Intensity (RDI)
Time Frame: Up to 30 weeks
RDI will be assessed using a threshold of greater than or equal to (>=) 80-percent.
Up to 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Craig Moskowitz, MD, University of Miami
  • Principal Investigator: Tracy E Crane, PhD, RDN, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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