慢性リンパ性白血病の参加者の健康関連の生活の質に対する個人の身体活動介入の利点 (QOLIBRI)
実際の臨床現場でイブルチニブを投与されている慢性リンパ性白血病患者の健康関連の生活の質に対する個人の身体活動介入の利点
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).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前：Study Contact
- 電話番号：844-434-4210
- メール：Participate-In-This-Study1@its.jnj.com
研究場所
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Toulouse、フランス、31059
- 募集
- Institut Universitaire du Cancer Toulouse Oncopole
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL).
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
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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). |
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. |
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Group 2: Standard of Care
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. Participants received ibrutinib as per their routine clinical practice settings. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：Baseline and Month 4.5
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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. |
Baseline and Month 4.5
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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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. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5
時間枠：Month 4.5 and Month 6.5
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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. |
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
時間枠：Month 6.5 and Month 12
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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. |
Month 6.5 and Month 12
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Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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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. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5
時間枠：Month 4.5 and Month 6.5
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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. |
Month 4.5 and Month 6.5
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Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12
時間枠：Month 6.5 and Month 12
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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. |
Month 6.5 and Month 12
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Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12
時間枠：Baseline, Month 6.5, and Month 12
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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. |
Baseline, Month 6.5, and Month 12
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Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5
時間枠：Month 4.5 and Month 6.5
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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. |
Month 4.5 and Month 6.5
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Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12
時間枠：Month 6.5 and Month 12
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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. |
Month 6.5 and Month 12
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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
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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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. |
Baseline, Month 4.5, Month 6.5, and Month 12
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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
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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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. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Total Sleep Time Using Connected Watch
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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Change from baseline in total sleep time (in hours) using connected watch will be assessed. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Total Sleep Score Using Connected Watch
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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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. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Sleep Stages Using Connected Watch
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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Change from baseline in sleep stages (deep/light) using connected watch will be assessed. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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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. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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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. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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Change from baseline in physical activity as assessed by number of steps per day using connected watch will be reported. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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Change from baseline in physical activity as assessed by the number of walking sessions per week using connected watch will be reported. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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Change from baseline in physical activity as assessed by the time of walking sessions per week using connected watch will be reported. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch
時間枠：Baseline, Month 4.5, Month 6.5, and Month 12
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Change from baseline in physical activity as assessed by the distance of walking sessions per week using connected watch will be reported. |
Baseline, Month 4.5, Month 6.5, and Month 12
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Percentage of Participants with Treatment-related Adverse Events
時間枠：Up to 30 months
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Percentage of participants with treatment-related adverse events especially musculoskeletal and cardiovascular treatment-related adverse events will be reported. |
Up to 30 months
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Time to Treatment Discontinuation (TTD)
時間枠：Months 6 and 12
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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. |
Months 6 and 12
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Reasons for Treatment Discontinuation
時間枠：Up to Month 12
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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. |
Up to Month 12
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Percentage of Participants Who Still Wear the Connected Watch
時間枠：Months 1, 3, 4.5, 6.5, and 12
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Percentage of participants who still wear the connected watch (adherence) will be assessed. |
Months 1, 3, 4.5, 6.5, and 12
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Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch)
時間枠：Months 1, 3, 4.5, 6.5, and 12
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Percentage of participants retained by the connected watch (start wearing the watch) will be assessed. |
Months 1, 3, 4.5, 6.5, and 12
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Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment
時間枠：During the first 6 months (Feasibility period)
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Percentage of participants agreed to participate in the study among eligible participants with CLL initiation ibrutinib treatment will be reported. |
During the first 6 months (Feasibility period)
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For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI
時間枠：Months 1, 3, 4.5, and 6.5
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Percentage of participants who still follow the IPAI among those who have started IPAI (Adherence) in group 1 will be assessed. |
Months 1, 3, 4.5, and 6.5
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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
時間枠：Months 1, 3, 4.5, and 4.6
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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. |
Months 1, 3, 4.5, and 4.6
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For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study
時間枠：Months 1 and 3
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Percentage of participants retained by the IPAI (first APA videoconference attended) among participants enrolled in the study will be assessed. |
Months 1 and 3
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For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study
時間枠：Month 4.5
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Percentage of participants who completed the supervised period among participants enrolled in the study will be assessed. |
Month 4.5
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For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study
時間枠：Month 6.5
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Percentage of participants who completed the unsupervised period among participants enrolled in the study will be assessed. |
Month 6.5
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For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale
時間枠：Months 4.5, 6.5, and 12
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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. |
Months 4.5, 6.5, and 12
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協力者と研究者
捜査官
捜査官
- スタディディレクター：Janssen Cilag S.A.S., France Clinical Trial、Janssen Cilag S.A.S.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 54179060CLL4033
- 54179060CLL4033 (その他の識別子：Janssen Research & Development, LLC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。