NCT06299540

Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants 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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Janssen Cilag S.A.S. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Type	Name	Description
BEHAVIORAL	Individual Physical Activity Intervention (IPAI)	No drug will be administered as a part of this study. The intervention will consist in an IPAI provided to participants for 6 months to practice physical activity in addition to their medical treatment in routine clinical practice settings. IPAI will be an adaptive program and will comprise two periods, the first period consisting in a supervised 4-month program and the second one in an unsupervised 2-month program to achieve greater autonomy.
DRUG	Ibrutinib	No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.

Timeline

• Start date: 2024-05-27
• Primary completion: 2026-09-30
• Completion: 2027-10-29
• First posted: 2024-03-08
• Last updated: 2026-04-13

Locations

1 site across 1 country: France