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

Janssen Cilag S.A.S.1 site in 1 country180 target enrollmentMay 27, 2024

ConditionsLeukemia, Lymphocytic, Chronic, B-Cell

InterventionsIndividual Physical Activity Intervention (IPAI)Ibrutinib

DrugsIbrutinib

Overview

Phase: N/A
Intervention: Individual Physical Activity Intervention (IPAI)
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Sponsor: Janssen Cilag S.A.S.
Enrollment: 180
Locations: 1
Primary Endpoint: 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
Status: Recruiting
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 27, 2024

End Date

October 29, 2027

Last Updated

19 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Janssen Cilag S.A.S.

Responsible Party

Sponsor

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

Arms & Interventions

Group 1: Individual Physical Activity Intervention

Participants with chronic lymphocytic leukemia (CLL) will be invited to perform physical activity according to a predefined intervention program. This program includes walking and weekly remote adapted physical activity sessions (2 sessions per week, the duration and difficulty of which will be adapted by the adapted physical activity \[APA\] trainer according to the Participant's abilities).

Intervention: Individual Physical Activity Intervention (IPAI)

Group 1: Individual Physical Activity Intervention

Intervention: Ibrutinib

Group 2: Standard of Care

Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team.

Intervention: Ibrutinib

Outcomes

Primary Outcomes

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

Time Frame: Baseline and Month 4.5

The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.

Secondary Outcomes

Change From Baseline in Total Sleep Time Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Sleep Stages Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
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(Baseline, Month 4.5, Month 6.5, and Month 12)
Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5(Month 4.5 and Month 6.5)
Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12(Month 6.5 and Month 12)
Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Total Sleep Score Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5(Month 4.5 and Month 6.5)
Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12(Month 6.5 and Month 12)
Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12(Baseline, Month 6.5, and Month 12)
Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5(Month 4.5 and Month 6.5)
Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12(Month 6.5 and Month 12)
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(Baseline, Month 4.5, Month 6.5, and Month 12)
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(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Percentage of Participants with Treatment-related Adverse Events(Up to 30 months)
Time to Treatment Discontinuation (TTD)(Months 6 and 12)
Reasons for Treatment Discontinuation(Up to Month 12)
Percentage of Participants Who Still Wear the Connected Watch(Months 1, 3, 4.5, 6.5, and 12)
Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch)(Months 1, 3, 4.5, 6.5, and 12)
Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment(During the first 6 months (Feasibility period))
For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI(Months 1, 3, 4.5, and 6.5)
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(Months 1, 3, 4.5, and 4.6)
For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study(Months 1 and 3)
For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study(Month 4.5)
For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study(Month 6.5)
For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale(Months 4.5, 6.5, and 12)
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(Baseline, Month 4.5, Month 6.5, and Month 12)
Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5(Month 4.5 and Month 6.5)
Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12(Month 6.5 and Month 12)
Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12(Baseline, Month 4.5, Month 6.5, and Month 12)
Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5(Month 4.5 and Month 6.5)
Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12(Month 6.5 and Month 12)
Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12(Baseline, Month 6.5, and Month 12)
Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5(Month 4.5 and Month 6.5)
Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12(Month 6.5 and Month 12)
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(Baseline, Month 4.5, Month 6.5, and Month 12)
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(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Total Sleep Time Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Total Sleep Score Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Sleep Stages Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch(Baseline, Month 4.5, Month 6.5, and Month 12)
Percentage of Participants with Treatment-related Adverse Events(Up to 30 months)
Time to Treatment Discontinuation (TTD)(Months 6 and 12)
Reasons for Treatment Discontinuation(Up to Month 12)
Percentage of Participants Who Still Wear the Connected Watch(Months 1, 3, 4.5, 6.5, and 12)
Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch)(Months 1, 3, 4.5, 6.5, and 12)
Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment(During the first 6 months (Feasibility period))
For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI(Months 1, 3, 4.5, and 6.5)
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(Months 1, 3, 4.5, and 4.6)
For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study(Months 1 and 3)
For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study(Month 4.5)
For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study(Month 6.5)
For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale(Months 4.5, 6.5, and 12)