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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
Study 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.Check my eligibility
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.See study design
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Assessment of Cancer Therapy (FACT) questionnaires.
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,446 Total Patients Enrolled
CLL Global Research FoundationUNKNOWN
1 Previous Clinical Trials
345 Total Patients Enrolled
Alessandra Ferrajoli, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
417 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any cancer other than non-melanoma skin cancer in the past year.I am less active than the study requires.I have not had major surgery in the last month.I do not speak English.I have a cognitive impairment.I am between 18-85 years old with confirmed CLL and can consent to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 (Waitlist)
- Group 2: Group 1 (Behavioral)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor recruiting individuals over the age of sixty?
"This study is actively seeking individuals aged 18 to 85."
Answered by AI
Is there still availability for participants in this clinical investigation?
"Clinicaltrials.gov confirms that this study, first published on May 17th 2023, is currently recruiting participants. It was last edited a day later on May 18th 2023."
Answered by AI
How many individuals have enlisted in this medical experiment?
"Affirmative. The information stored on clinicaltrials.gov confirms that this research study, which was initially posted on May 17th 2023, is actively searching for participants. Approximately 30 individuals need to be selected from one medical site."
Answered by AI
Do I qualify to participate in this medical experiment?
"Potential participants of this trial must have chronical lymphocytic leukemia and be aged between 18 to 85. Up to 30 patients can take part in the study."
Answered by AI
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