Back to resultsLifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE-L)
Primary Purpose
Non Hodgkin Lymphoma, Hodgkin Lymphoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LIFE-L Mediterranean Diet
LIFE-L Home-Based Exercise Program
Supportive Materials
Sponsored by
About this trial
This is an interventional other trial for Non Hodgkin Lymphoma focused on measuring Mediterranean Diet, Exercise Program
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 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs: R-CHOP; Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like regimen Bendamustine and Rituximab (BR) Brentuximab Vedotin, Doxorubicin, Vinblastine, and Dacarbazine (BV-AVD) or Doxorubicin, Bleomycin, Vinblastine, And Dacarbazine (ABVD) or checkpoint inhibitor+ Doxorubicin, Vinblastine, and Dacarbazine (AVD). Approval from treating oncologist, confirmed via email or in writing Delivery of chemotherapy treatments at one of the following institutions: Sylvester Comprehensive Cancer Center University of Miami Hospital/University of Miami Health Systems (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 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
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
LIFE-L Group
Control Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Average Relative Dose Intensity (RDI)
RDI will be assessed using a threshold of greater than or equal to (>=) 80-percent.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05839210
Brief Title
Lifestyle Intervention of Food and Exercise for Lymphoma Survivors
Acronym
LIFE-L
Official Title
Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
April 26, 2025 (Anticipated)
Study Completion Date
April 26, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma, Hodgkin Lymphoma
Keywords
Mediterranean Diet, Exercise Program
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LIFE-L Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
LIFE-L Mediterranean Diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LIFE-L Home-Based Exercise Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Materials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Survivors who participate
Description
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.
Time Frame
Up to 12 months
Title
Percentage of Participants Completing Intervention Sessions
Description
Percentage of intervention session completion at the end of treatment will be assessed, using a threshold of greater than or equal to (>=) 80-percent.
Time Frame
Up to 26 weeks (Post-Intervention)
Title
Change in percentage of participant satisfaction
Description
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.
Time Frame
4 weeks (post-intervention), up to 30 weeks
Secondary Outcome Measure Information:
Title
Average Relative Dose Intensity (RDI)
Description
RDI will be assessed using a threshold of greater than or equal to (>=) 80-percent.
Time Frame
Up to 30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:
R-CHOP; Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like regimen
Bendamustine and Rituximab (BR)
Brentuximab Vedotin, Doxorubicin, Vinblastine, and Dacarbazine (BV-AVD) or Doxorubicin, Bleomycin, Vinblastine, And Dacarbazine (ABVD) or checkpoint inhibitor+ Doxorubicin, Vinblastine, and Dacarbazine (AVD).
Approval from treating oncologist, confirmed via email or in writing
Delivery of chemotherapy treatments at one of the following institutions:
Sylvester Comprehensive Cancer Center
University of Miami Hospital/University of Miami Health Systems (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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy E Crane, PhD, RDN
Phone
305-243-8255
Email
tecrane@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy E Crane, Phd, RDN
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Moskowitz, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy E Crane, PhD, RDN
Phone
305-243-8255
Email
tecrane@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Tracy E Crane, PhD, RDN
First Name & Middle Initial & Last Name & Degree
Craig Moskowitz, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Lifestyle Intervention of Food and Exercise for Lymphoma Survivors
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