Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

Not Applicable

Recruiting

• Conditions: Non Hodgkin Lymphoma; Hodgkin Lymphoma
• Interventions: Behavioral: LIFE-L Mediterranean Diet; Behavioral: LIFE-L Home-Based Exercise Program; Behavioral: Supportive Materials

• Registration Number: NCT05839210
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-19
• Study Start: 2023-04-26
• Study First Posted: 2023-05-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIFE-L Group	LIFE-L Home-Based Exercise Program	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.
LIFE-L Group	LIFE-L Mediterranean Diet	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.
LIFE-L Group	Supportive Materials	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.
Control Group	Supportive Materials	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Completing Intervention Sessions	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	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.
Percentage of Survivors who participate	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.

Secondary Outcome Measures

Name	Time	Method
Average Relative Dose Intensity (RDI)	Up to 30 weeks	RDI will be assessed using a threshold of greater than or equal to (\>=) 80-percent.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States