Actively Recruiting
Benefits of an Individual Physical Activity Intervention on Health-related Quality of Life in Patients With Chronic Lymphocytic Leukemia Receiving Ibrutinib in Real-life Practice
Led by Janssen Cilag S.A.S. · Updated on 2026-06-05
180
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how an individual physical activity intervention (IPAI) affects health-related quality of life (HRQoL) in people with chronic lymphocytic leukemia (CLL) who are starting or have recently started treatment with ibrutinib. The goal is to see if this physical activity program can improve quality of life during routine clinical care. HRQoL will be measured using the Functional Assessment of Cancer Therapy - General scale (FACT-G). Participants with CLL will be invited to follow a tailored physical activity program that includes walking and twice-weekly remote adapted physical activity sessions. These sessions will be adjusted by a trainer to fit each person's abilities. The program lasts six months, with a first four-month supervised phase and a following two-month unsupervised phase to encourage independence. Participants in a comparison group will continue their usual physical activity and medical care. Throughout the study, participants will wear a connected watch continuously to monitor activity and sleep. Researchers will assess changes in quality of life, fatigue, sleep, anxiety, depression, and physical fitness at baseline, 4.5 months, 6.5 months, and 12 months. Additional measures include treatment-related events and adherence to the physical activity program. The study aims to collect comprehensive data on how the intervention impacts participants’ well-being and daily function over time.
CONDITIONS
Brief Title
Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants newly treated with ibrutinib for first line or relapsed chronic lymphocytic leukemia (treatment started within the last 8 days)
- Participants agreed to follow the individual physical activity intervention (IPAI)
- Participants have access to a compatible electronic device such as a smartphone, laptop, or tablet
- Participants have internet access at home and an email address
- Participants agreed to wear a connected watch 24 hours a day for the duration of the study
You will not qualify if you...
- Pregnant participants or those planning to become pregnant during the study
- Participants unable or considered unsafe to practice physical activity
- Participants who have received an investigational drug or invasive investigational device within 90 days before inclusion
- Participants currently involved in another interventional study
- Participants with probable difficulties in using the digital tool independently
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants follow an individual physical activity intervention consisting of a supervised 4-month program followed by a 2-month unsupervised program to encourage physical activity in addition to their routine medical treatment.
Weekly remote adapted physical activity sessions (2 sessions per week) and regular assessments at baseline, Month 4.5, and Month 6.5
Duration - 6 months
Participants are monitored for health-related quality of life and physical activity outcomes up to 12 months after starting the intervention.
Assessments at Month 6.5 and Month 12
Trial Site Locations
Total: 1 location
1
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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