Impact of physical activity on quality of life for patients with chronic lymphocytic leukemia
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
This study is testing if adding physical activity to the routine of patients with chronic lymphocytic leukemia starting ibrutinib treatment can improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Cilag S.A.S. Industry-sponsored |
| Drugs / interventions | ibrutinib |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06299540 on ClinicalTrials.gov |
What this trial studies
This study evaluates how an individual physical activity intervention (IPAI) affects health-related quality of life (HRQoL) in patients with chronic lymphocytic leukemia (CLL) who are starting treatment with ibrutinib. Participants will be monitored using the functional assessment of cancer therapy - general scale (FACT-G) to assess changes in their quality of life. The intervention is designed for patients who have recently begun treatment for CLL, focusing on integrating physical activity into their routine. The study is observational and aims to gather data in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates are patients newly treated with ibrutinib for first line or relapsed CLL who can commit to the physical activity intervention.
Not a fit: Patients who are pregnant, unable to safely engage in physical activity, or currently involved in other interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for patients undergoing treatment for chronic lymphocytic leukemia.
How similar studies have performed: While there is limited data on similar interventions specifically for CLL, studies in other cancer types have shown positive outcomes from physical activity interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants newly treated with ibrutinib for first line or relapsed CLL (treatment is being initiated or has been initiated within the last 8 days as a maximum) * Participants agreed to follow the individual physical activity intervention (IPAI) * Participants using or having access to a compatible and appropriate electronic device such as smartphone, laptop or tablet * Participants with Internet access at home and email address * Participants agreed to wear a connected watch 24 hours a day for all the duration of the study Exclusion Criteria: * Pregnant participants or planning to become pregnant while enrolled in this study * Participants with inability or deemed unsafe to practice physical activity * Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the inclusion visit * Participants who are currently involved in an interventional study * Participants with probable difficulties in using the digital tool autonomously
Where this trial is running
Toulouse
- Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.