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Behavioral Interventions for Chronic Lymphocytic Leukemia

N/A

Recruiting

Led By Alessandra Ferrajoli, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if exercise and diet can help reduce fatigue in people with CLL.

Who is the study for?

This trial is for adults aged 18-85 with Chronic Lymphocytic Leukemia (CLL) who feel tired and aren't very active. They must be able to give consent. People won't qualify if they're already as active as the study requires.

What is being tested?

The trial tests whether using a Fitbit activity tracker and following weight management plans can reduce fatigue in CLL survivors. Participants will be randomly assigned to start these interventions immediately or after a waiting period.

What are the potential side effects?

Since this trial involves exercise and questionnaires, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness or strain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Assessment of Cancer Therapy (FACT) questionnaires.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (Waitlist)Experimental Treatment2 Interventions

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 II: Group 1 (Behavioral)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaires

2013

Completed Phase 2

~4280

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