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Trial Title:
HEALTH4CLL2: a Randomized Waitlist Control Trial of Behavioral Interventions in Patients with Chronic Lymphocytic Leukemia
NCT ID:
NCT05879133
Condition:
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Questionnaires
Description:
Survey
Arm group label:
Group 1 (Behavioral)
Arm group label:
Group 2 (Waitlist)
Intervention type:
Other
Intervention name:
Fit Bit
Description:
measures physical activity
Arm group label:
Group 1 (Behavioral)
Arm group label:
Group 2 (Waitlist)
Summary:
To learn if exercise and weight management can help to improve feelings of fatigue in CLL
survivors.
Detailed description:
Primary Objective:
--Evaluate the impact of an organized, longitudinal, diet and exercise training program
on fatigue as assessed by the Functional Assessment of Cancer Therapy (FACT) score in
patients with CLL.
Secondary Objectives:
--Assess changes in physical activity, dietary behavior, physical function using the
PROMIS physical function questionnaire and performance tests of physical function, body
mass index (BMI) and global quality of life. Additionally, we will assess changes in
fecal microbiome composition, metabolic parameters including a comprehensive lipid panel,
glucose, insulin, TNF alpha, IL6, leptin, resistin, adiponectin, IGF1 and IGFBP1 and
immunologic function as assessed by T cell and monocyte phenotypic and functional assays
in patients with CLL after participation in the behavioral intervention.
Exploratory Objectives:
-- Identify differences in the metabolic, immunologic and fecal microbiome composition in
patients with CLL who have a high CLL comorbidity index score (CLL-CI) compared to
patients with CLL and a low CLL-CI score. And, investigate the association of comorbidity
score, disease features, CLL-specific prognostic factors and clinical outcomes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adults age 18-85 years of age with a histologically confirmed diagnosis of CLL and
the ability to provide signed informed consent.
- Self-reported physical activity will be assessed prior to enrollment and patients
with a physical activity level below the level prescribed in our study will be
eligible for inclusion.
Exclusion Criteria:
- Other active malignancy within 1 year of study enrollment (excluding non-melanoma
skin cancer)
- Richter's transformation, another medical condition which would prevent safe
participation in the behavioral intervention
- Major surgery within 1 month of enrollment
- Non-English speakers
- Cognitively impaired adults
- Pregnancy.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alessandra Ferrajoli, MD
Contact backup:
Last name:
Alessandra Alessandra, MD
Start date:
May 17, 2023
Completion date:
July 3, 2025
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
CLL Global Research Foundation
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05879133
http://www.mdanderson.org
