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).
Study Type
OBSERVATIONAL
Enrollment
180
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.
No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
RECRUITINGChange 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
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.
Time frame: Baseline and Month 4.5
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
The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 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-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: 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
The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 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-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Month 4.5 and Month 6.5
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Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12
The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 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-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: 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
The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 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 TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: 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
The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 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 TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: 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
The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 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 TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Month 6.5 and Month 12
Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12
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.
Time frame: Baseline, Month 6.5, and Month 12
Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5
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.
Time frame: Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12
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.
Time frame: 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
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.
Time frame: 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
The FACIT-fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists of 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Total Sleep Time Using Connected Watch
Change from baseline in total sleep time (in hours) using connected watch will be assessed.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Total Sleep Score Using Connected Watch
Change from baseline in total sleep score (time asleep/time in bed) based on duration, regularity, depth and interruption using connected watch will be assessed.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Sleep Stages Using Connected Watch
Change from baseline in sleep stages (deep/light) using connected watch will be assessed.
Time frame: 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
The HAD scale is a 14-items measure that assesses anxiety and depressive disorders. The scale includes seven questions related to anxiety (total A) and seven others to the depressive dimension (total D). Each item is rated from 0 to 3. Two scores are derived from the scale, one related to anxiety and the other related to depression (maximum score for each score = 21). Higher scores indicate increased anxiety or depression.
Time frame: 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
The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. It is easy to administer, better tolerated, and more reflective of activities of daily living than the other walk tests.
Time frame: 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
Change from baseline in physical activity as assessed by number of steps per day using connected watch will be reported.
Time frame: 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
Change from baseline in physical activity as assessed by the number of walking sessions per week using connected watch will be reported.
Time frame: 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
Change from baseline in physical activity as assessed by the time of walking sessions per week using connected watch will be reported.
Time frame: 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
Change from baseline in physical activity as assessed by the distance of walking sessions per week using connected watch will be reported.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Percentage of Participants with Treatment-related Adverse Events
Percentage of participants with treatment-related adverse events especially musculoskeletal and cardiovascular treatment-related adverse events will be reported.
Time frame: Up to 30 months
Time to Treatment Discontinuation (TTD)
TTD is defined as the time between the first day of ibrutinib treatment and the day that ibrutinib is definitely stopped for whatever reason or death.
Time frame: Months 6 and 12
Reasons for Treatment Discontinuation
Number of participants in each reason for treatment discontinuation will be reported. Reasons for treatment discontinuation are defined as: adverse events, lack of efficacy, patient's convenience, physician's decision, progression, death or other.
Time frame: Up to Month 12
Percentage of Participants Who Still Wear the Connected Watch
Percentage of participants who still wear the connected watch (adherence) will be assessed.
Time frame: Months 1, 3, 4.5, 6.5, and 12
Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch)
Percentage of participants retained by the connected watch (start wearing the watch) will be assessed.
Time frame: 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
Percentage of participants agreed to participate in the study among eligible participants with CLL initiation ibrutinib treatment will be reported.
Time frame: 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
Percentage of participants who still follow the IPAI among those who have started IPAI (Adherence) in group 1 will be assessed.
Time frame: 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
Percentage of participants who follow the adapted physical activity sessions, the walking objectives and the APA appointment as scheduled with the APA among those who have started IPAI (Compliance) in group 1 will be assessed.
Time frame: 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
Percentage of participants retained by the IPAI (first APA videoconference attended) among participants enrolled in the study will be assessed.
Time frame: Months 1 and 3
For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study
Percentage of participants who completed the supervised period among participants enrolled in the study will be assessed.
Time frame: Month 4.5
For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study
Percentage of participants who completed the unsupervised period among participants enrolled in the study will be assessed.
Time frame: Month 6.5
For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale
Participant's' satisfaction will be assessed by Likert scales at Months 4.5 and 6.5 regarding coaching, proposed sessions, program content, program duration, impact on APA practice, overall satisfaction, willingness to continue and recommendation to others. Likert scales will assess participant's' satisfaction at Month 12 regarding impact on APA practice, overall satisfaction, willingness to continue and recommendation to others. Only one question is quantitative with score range from 0 (not at all satisfied) to 10 (totally satisfied) for global satisfaction. Participants are considered satisfied when score is greater than or equal to (\>=) 6 and highly-satisfied when score is \>=8. All other questions are qualitative and have 5-level Likert scales including: very satisfied, rather satisfied, neither satisfied nor dissatisfied, not really satisfied, not at all satisfied.
Time frame: Months 4.5, 6.5, and 12