nctId: NCT06299540 id: 54179060CLL4033 id: 54179060CLL4033 type: OTHER domain: Janssen-Cilag France briefTitle: Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia acronym: QOLIBRI overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-09-30 date: 2026-09-30 date: 2024-03-08 date: 2024-04-25 name: Janssen Cilag S.A.S. class: INDUSTRY briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 256 type: ESTIMATED name: Individual Physical Activity Intervention (IPAI) name: Ibrutinib measure: Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5 measure: Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12 measure: Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12 measure: Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12 measure: Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12 measure: Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12 measure: Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12 measure: Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline measure: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in the Pittsburgh Sleep Quality Index (PSQI) Total Score and Sub Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Total Sleep Time Using Connected Watch measure: Change From Baseline in Total Sleep Score Using Connected Watch measure: Change From Baseline in Sleep Stages Using Connected Watch measure: Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch measure: Percentage of Participants with Treatment-related Adverse Events measure: Time to Treatment Discontinuation (TTD) measure: Reasons for Treatment Discontinuation measure: Percentage of Participants Who Still Wear the Connected Watch measure: Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch) measure: Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment measure: For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI measure: For Group 1: Percentage of Participants Who Follow the Adapted Physical Activity (APA) Sessions, the Walking Objectives and the APA Appointment as Scheduled With the APA Among Those Who Have Started IPAI measure: For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study measure: For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study measure: For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study measure: For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False