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Recruiting NCT05839210

Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

No phase Interventional Non Hodgkin Lymphoma Hodgkin Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LIFE-L Mediterranean Diet, LIFE-L Home-Based Exercise Program, Supportive Materials.
Who it may be relevant to
Registry conditions: Non Hodgkin Lymphoma, Hodgkin Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Percentage of Survivors who participate [Time frame: Up to 12 months]
  • Percentage of Participants Completing Intervention Sessions [Time frame: Up to 26 weeks (Post-Intervention)]
  • Change in percentage of participant satisfaction [Time frame: 4 weeks (post-intervention), up to 30 weeks]
Secondary outcome measures (1)
  • Average Relative Dose Intensity (RDI) [Time frame: Up to 30 weeks]

Eligibility criteria

Inclusion criteria

  • 18 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
  • BR
  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT05839210 · 20221298

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗