Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Quality of Life

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Amino Acids

Ibrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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).

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

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.

Individual Physical Activity Intervention (IPAI)

No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.

Study Contact

Janssen Cilag S.A.S., France Clinical Trial

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).

Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia

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 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.

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.

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.

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.

PSQI is used to detect sleep disturbance or deficits. It contains 19 self-rated items that are combined to form seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction The PSQI has a scoring key that can be used to calculate a participant's seven sub scores, which range from 0 to 3. The sub scores are added together to produce a "global" score that ranges from 0 to 21. A global score of 5 or higher denotes poor sleep quality.

Change from baseline in total sleep time (in hours) using connected watch will be assessed.

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.

Change from baseline in sleep stages (deep/light) using connected watch will be assessed.

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.

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.

Change from baseline in physical activity as assessed by number of steps per day using connected watch will be reported.

Change from baseline in physical activity as assessed by the number of walking sessions per week using connected watch will be reported.

Change from baseline in physical activity as assessed by the time of walking sessions per week using connected watch will be reported.

Change from baseline in physical activity as assessed by the distance of walking sessions per week using connected watch will be reported.

Percentage of participants with treatment-related adverse events especially musculoskeletal and cardiovascular treatment-related adverse events will be reported.

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.

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.

Percentage of participants who still wear the connected watch (adherence) will be assessed.

Percentage of participants retained by the connected watch (start wearing the watch) will be assessed.

Percentage of participants agreed to participate in the study among eligible participants with CLL initiation ibrutinib treatment will be reported.

Percentage of participants who still follow the IPAI among those who have started IPAI (Adherence) in group 1 will be assessed.

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.

Percentage of participants retained by the IPAI (first APA videoconference attended) among participants enrolled in the study will be assessed.

Percentage of participants who completed the supervised period among participants enrolled in the study will be assessed.

Percentage of participants who completed the unsupervised period among participants enrolled in the study will be assessed.

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.

Spots Global Cancer Trial Database for Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial