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

University of Miami

Status: Enrolling

Conditions: Hodgkin Lymphoma; Non Hodgkin Lymphoma

Treatments: Behavioral: LIFE-L Home-Based Exercise Program; Behavioral: Supportive Materials; Behavioral: LIFE-L Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05839210

20221298

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

LIFE-L Group

Experimental group

Description:

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.

Treatment:

Behavioral: LIFE-L Mediterranean Diet

Behavioral: Supportive Materials

Behavioral: LIFE-L Home-Based Exercise Program

Control Group

Other group

Description:

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.

Treatment:

Behavioral: Supportive Materials