Clinical trial NCT06299540: Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Janssen Cilag S.A.S.
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL).

Brief 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).


Eligibility 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

Primary outcomes:
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
timeFrame: Baseline and Month 4.5
Secondary outcomes:
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
timeFrame: Baseline, 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
timeFrame: Month 4.5 and Month 6.5
measure: Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12
timeFrame: Month 6.5 and 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
timeFrame: Baseline, 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
timeFrame: Month 4.5 and Month 6.5
measure: Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12
timeFrame: Month 6.5 and Month 12
measure: Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12
timeFrame: Baseline, Month 6.5, and Month 12
measure: Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5
timeFrame: Month 4.5 and Month 6.5
measure: Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12
timeFrame: Month 6.5 and 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
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
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
timeFrame: Baseline, 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
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
measure: Change From Baseline in Total Sleep Time Using Connected Watch
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
measure: Change From Baseline in Total Sleep Score Using Connected Watch
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
measure: Change From Baseline in Sleep Stages Using Connected Watch
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
measure: Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12
timeFrame: Baseline, 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
timeFrame: Baseline, 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
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
measure: Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
measure: Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
measure: Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch
timeFrame: Baseline, Month 4.5, Month 6.5, and Month 12
measure: Percentage of Participants with Treatment-related Adverse Events
timeFrame: Up to 30 months
measure: Time to Treatment Discontinuation (TTD)
timeFrame: Months 6 and 12
measure: Reasons for Treatment Discontinuation
timeFrame: Up to Month 12
measure: Percentage of Participants Who Still Wear the Connected Watch
timeFrame: Months 1, 3, 4.5, 6.5, and 12
measure: Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch)
timeFrame: Months 1, 3, 4.5, 6.5, and 12
measure: Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment
timeFrame: During the first 6 months (Feasibility period)
measure: For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI
timeFrame: Months 1, 3, 4.5, and 6.5
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
timeFrame: Months 1, 3, 4.5, and 4.6
measure: For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study
timeFrame: Months 1 and 3
measure: For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study
timeFrame: Month 4.5
measure: For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study
timeFrame: Month 6.5
measure: For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale
timeFrame: Months 4.5, 6.5, and 12
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
Study officials:
affiliation: Janssen Cilag S.A.S.
name: Janssen Cilag S.A.S., France Clinical Trial
role: STUDY_DIRECTOR
References: