protocolSection identificationModule nctId: NCT06299540, orgStudyIdInfo id: 54179060CLL4033, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Janssen Cilag S.A.S., class: INDUSTRY, descriptionModule 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)., conditionsModule conditions: Leukemia, Lymphocytic, Chronic, B-Cell, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 256, type: ESTIMATED, armsInterventionsModule interventions name: Individual Physical Activity Intervention (IPAI), interventions name: Ibrutinib, outcomesModule primaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes measure: Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5, secondaryOutcomes measure: Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12, secondaryOutcomes measure: Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12, secondaryOutcomes measure: Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5, secondaryOutcomes measure: Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12, secondaryOutcomes measure: Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12, secondaryOutcomes measure: Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5, secondaryOutcomes measure: Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes measure: Change From Baseline in Total Sleep Time Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Total Sleep Score Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Sleep Stages Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12, secondaryOutcomes 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, secondaryOutcomes measure: Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch, secondaryOutcomes measure: Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch, secondaryOutcomes measure: Percentage of Participants with Treatment-related Adverse Events, secondaryOutcomes measure: Time to Treatment Discontinuation (TTD), secondaryOutcomes measure: Reasons for Treatment Discontinuation, secondaryOutcomes measure: Percentage of Participants Who Still Wear the Connected Watch, secondaryOutcomes measure: Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch), secondaryOutcomes measure: Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment, secondaryOutcomes measure: For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI, secondaryOutcomes 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, secondaryOutcomes measure: For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study, secondaryOutcomes measure: For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study, secondaryOutcomes measure: For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study, secondaryOutcomes measure: For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False