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

NCT05879133 | Active Not Recruiting

• 2 other identifiers: 2022-0411NCI-2023-04161
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

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

  through study completion; an average of 1 year.

Study Arms (2)

Group 1 (Behavioral)

EXPERIMENTAL

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

Group 2 (Waitlist)

EXPERIMENTAL

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

Questionnaires BEHAVIORAL

Survey

Group 1 (Behavioral); Group 2 (Waitlist)

Fit Bit OTHER

measures physical activity

Group 1 (Behavioral); Group 2 (Waitlist)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18-85 years of age with a histologically confirmed diagnosis of CLL and the ability to provide signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• CLL Global Research Foundation: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alessandra Ferrajoli, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: May 17, 2023
• Primary Completion (Estimated): July 3, 2027
• Study Completion (Estimated): July 3, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)