Leukemia, Lymphocytic, Chronic, B-CellQOLIBRINCT06299540
Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Cilag S.A.S. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell
- What is being tested?
- Individual Physical Activity Intervention (IPAI) and Ibrutinib
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2024to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059
About this study
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
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
- Being tested
- Individual Physical Activity Intervention (IPAI), Ibrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Physical Activity Intervention (IPAI)Behavioural
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.
IbrutinibDrug
No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Individual Physical Activity Intervention (IPAI); Drug: Ibrutinib | |
| Group 2: Standard of Care | Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team. Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline and Month 4.5
Secondary outcomes (32)
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.
Measured: 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.
Measured: Month 4.5 and Month 6.5
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Months 4.5, 6.5, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start27 May 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Cilag S.A.S., France Clinical Trial, Study director, Janssen Cilag S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299540
- Sponsor's protocol ID
- 54179060CLL4033
- Other IDs
- 54179060CLL4033
- Acronym
- QOLIBRI
- Status last verified
- Nov 2026
- First submitted
- 1 Mar 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06299540
- Acronym / sponsor ID
- QOLIBRI / 54179060CLL4033
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Janssen Cilag S.A.S.Industry (pharma, biotech, devices)
- Study start
- 27 May 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Individual Physical Activity Intervention | – | Behavioral: Individual Physical Activity Intervention (IPAI), Drug: IbrutinibParticipants 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). |
| Group 2: Standard of Care | – | Drug: IbrutinibParticipants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Physical Activity Intervention (IPAI)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. | Behavioural | Group 1: Individual Physical Activity Intervention |
| IbrutinibNo drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings. | Drug | Group 1: Individual Physical Activity Intervention, Group 2: Standard of Care |
Primary outcome
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.
32 secondary outcomes
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
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
Time frame: Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12
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
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
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
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
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
Time frame: Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12
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
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
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Total Sleep Time Using Connected Watch
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Total Sleep Score Using Connected Watch
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Sleep Stages Using Connected Watch
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
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
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
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
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
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
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Percentage of Participants with Treatment-related Adverse Events
Time frame: Up to 30 months
Time to Treatment Discontinuation (TTD)
Time frame: Months 6 and 12
Reasons for Treatment Discontinuation
Time frame: Up to Month 12
Percentage of Participants Who Still Wear the Connected Watch
Time frame: Months 1, 3, 4.5, 6.5, and 12
Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch)
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
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
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
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
Time frame: Months 1 and 3
For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study
Time frame: Month 4.5
For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study
Time frame: Month 6.5
For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale
Time frame: Months 4.5, 6.5, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Cilag S.A.S., France Clinical Trial study director
Janssen Cilag S.A.S.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Cilag S.A.S. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline and Month 4.5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.