CClinicalTrials.gg
Active, not recruitingNCT05879133Updated Sep 18, 2026

HEALTH4CLL2: A Randomized Waitlist Control Trial of Behavioral Interventions in Patients With Chronic Lymphocytic Leukemia

An interventional study of Questionnaires and Fit Bit in Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

To learn if exercise and weight management can help to improve feelings of fatigue in CLL survivors.

Read the 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.

02

Conditions studied

  • Chronic Lymphocytic Leukemia
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 1,325 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Group 1 (Behavioral)

    Participants are randomly assigned a study group, pariticipants will be given the following: * A Fitbit to wear every day during the study. A Fitbit is a physical activity tracking device that will help measure your physical activity. Participants will also receive a Fitbit Aria weight scale. Participants need to create a Fitbit account on the Fitbit website, which will allow participants to track your physical activity and log your diet information and weight. A member of the study team will call you or help you in-person (if you are in the clinic) to help set up the Fitbit and scale. * Resistance bands with an instructional video on how to use them. * Educational materials, such as handouts about diabetes prevention, as well as written/verbal/video instructions on setting up the Fitbit and scale. This will also include information about online safety/privacy.

    Behavioral: Questionnaires · Other: Fit Bit

  • Experimental
    Group 2 (Waitlist)

    Participants are randomly assigned a study group, pariticipants will be given the following: * A Fitbit to wear every day during the study. A Fitbit is a physical activity tracking device that will help measure your physical activity. Participants will also receive a Fitbit Aria weight scale. Participants need to create a Fitbit account on the Fitbit website, which will allow participants to track your physical activity and log your diet information and weight. A member of the study team will call you or help you in-person (if you are in the clinic) to help set up the Fitbit and scale. * Resistance bands with an instructional video on how to use them. * Educational materials, such as handouts about diabetes prevention, as well as written/verbal/video instructions on setting up the Fitbit and scale. This will also include information about online safety/privacy.

    Behavioral: Questionnaires · Other: Fit Bit

Interventions

  • BehavioralQuestionnaires

    Survey

  • OtherFit Bit

    measures physical activity

06

What researchers measure

Primary outcomes

  1. Functional Assessment of Cancer Therapy (FACT) questionnaires.

    Score Scale ranges (0-4) 0-Not at all 1-A little bit 3-Somewhat 4-Quite a bit 5-Very much

    Time frame: through study completion; an average of 1 year.

07

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05879133
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
CLL Global Research Foundation
Responsible party
Sponsor
First posted
May 30, 2023
Start date
May 17, 2023
Primary completion
Jul 3, 2027 (estimated)
Completion
Jul 3, 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Alessandra Ferrajoli, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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