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

NCT ID: NCT05879133

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2027-07-03

Brief 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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Questionnaires

Intervention Type: BEHAVIORAL

Survey

Fit Bit

Intervention Type: OTHER

measures physical activity

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.

Group Type: EXPERIMENTAL

Questionnaires

Intervention Type: BEHAVIORAL

Survey

Fit Bit

Intervention Type: OTHER

measures physical activity

Interventions

Questionnaires

Survey

Intervention Type: BEHAVIORAL

Fit Bit

measures physical activity

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CLL Global Research Foundation

UNKNOWN

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandra Ferrajoli, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alessandra Ferrajoli, MD

Role: CONTACT

aferrajo@mdanderson.org

(713) 792-2063

Facility Contacts

Alessandra Ferrajoli, MD

Role: primary

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2023-04161

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0411

Identifier Type: -

Identifier Source: org_study_id