Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

Hodgkin Lymphoma Clinical Trial

— LIFE-L  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839210
• Other study ID #: 20221298
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2023
• Est. completion date: April 26, 2025

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Tracy E Crane, PhD, RDN
• Phone: 305-243-8255
• Email: tecrane[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 26, 2025
• Est. primary completion date: April 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Lymphoma
• Lymphoma
• Non Hodgkin Lymphoma

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	Average Relative Dose Intensity (RDI)	RDI will be assessed using a threshold of greater than or equal to (>=) 80-percent.	Up to 30 weeks