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A Study to Evaluate Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia
| Condition or disease | Intervention/treatment |
|---|---|
| CLL | Other: Standard of Care |
| Study Type : | Observational |
| Estimated Enrollment : | 50 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | "Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia (CLL): Argentinian Experience" |
| Actual Study Start Date : | August 12, 2019 |
| Estimated Primary Completion Date : | August 2021 |
| Estimated Study Completion Date : | December 15, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Single Group Study. Patients with CLL receiving ibrutinib.
In this study the investigator does not assign specific interventions to the study participants. Participants will receive interventions as part of routine medical care, and the investigator will observe the effect of the intervention. This study will collect prospective real-world data to describe the quality of life (QOL) in patients with CLL receiving ibrutinib in routine Argentinian clinical practice over a 12-month follow-up period. The primary data source for this observational study will be the medical records of each enrolled patient, as well as questionnaires concerning quality of life. Data will be collected at baseline and on months 1,3,6 and 12 during a prospective period. |
Other: Standard of Care
Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 12 months.
|
- Change From Baseline [ Time Frame: 6 months ]
The FACIT (Functional Assessment of Chronic Illness Therapy) fatigue scale is a self-assessment questionnaire with a 7-day recall period and 13 items evaluating fatigue and its impact on daily life activities. Fatigue is scored 0-52. 0= severe fatigue; 52= no fatigue.
Number of patients with an improvement of at least 3 points in FACIT score (Minimally Important Difference).
This study is assessing a Change from Baseline Fatigue at 6 months.
- Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L) [ Time Frame: At 0,1,3,6,12 months ]
The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Number of patients with improvements in the EQ5D domains by analyzing the variation in each domain and index during follow-up at different time points.
- Number of patients with Clinically Significant Change in hemoglobin [ Time Frame: At 0,1,3,6,12 months ]Number of Participants with Clinically Significant Change in hemoglobin will be determined
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Written informed consent obtained prior to any screening procedure
- Patients 18 years or older, to be treated with Ibrutinib, able to answer the complete QoL questionnaires.
- Diagnosis of CLL, according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, with pathology confirmation (World Health Organization 2008).
- Patients with CLL in first-line or with prior therapies or treatment-naïve patients that harbours deletion 17p according to fluorescence in situ hybridization (FISH) standards with an indication of treatment with ibrutinib.
Exclusion Criteria:
- Pregnant and breast-feeding patients
- Impairment of ingestion and/or absorption of ibrutinib
- Mental or physical limitation to complete the QoL questionnaires.
| Contact: Maria Jose Mela, PI | 541148771053 | mjmela@fundaleu.org.ar | |
| Contact: Mariana Juni, SC | 541148771070 | mjuni@fundaleu.org.ar |
| Argentina | |
| Fundaleu | Recruiting |
| Buenos Aires, Argentina, 1114 | |
| Contact: Maria Jose Mela, MD 541148771053 mjmela@fundaleu.org.ar | |
| Contact: Mariana Juni, SC 541148771070 mjuni@fundaleu.org.ar | |
| Principal Investigator: | Maria Jose Mela, MD | Fundaleu | |
| Study Director: | Miguel A Pavlovsky, MD | Fundaleu |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 8, 2019 | ||||||||
| First Posted Date | July 11, 2019 | ||||||||
| Last Update Posted Date | October 8, 2020 | ||||||||
| Actual Study Start Date | August 12, 2019 | ||||||||
| Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Change From Baseline [ Time Frame: 6 months ] The FACIT (Functional Assessment of Chronic Illness Therapy) fatigue scale is a self-assessment questionnaire with a 7-day recall period and 13 items evaluating fatigue and its impact on daily life activities. Fatigue is scored 0-52. 0= severe fatigue; 52= no fatigue.
Number of patients with an improvement of at least 3 points in FACIT score (Minimally Important Difference).
This study is assessing a Change from Baseline Fatigue at 6 months.
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L) [ Time Frame: At 0,1,3,6,12 months ] The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Number of patients with improvements in the EQ5D domains by analyzing the variation in each domain and index during follow-up at different time points.
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
Number of patients with Clinically Significant Change in hemoglobin [ Time Frame: At 0,1,3,6,12 months ] Number of Participants with Clinically Significant Change in hemoglobin will be determined
|
||||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | A Study to Evaluate Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia | ||||||||
| Official Title | "Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia (CLL): Argentinian Experience" | ||||||||
| Brief Summary | The aim of this study is to evaluate the impact of Ibrutinib monotherapy in the QoL of subjects with Chronic Lymphocytic Leukemia (CLL) based in European Quality of Life 5 Dimensions (EQ-5D) and FACIT- fatigue questionnaires assessment from baseline to 1 year of treatment in Argentinian routine clinical practice. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | This study includes patients with diagnosis of CLL with prescribed ibrutinib monotherapy as first-line or with prior therapies before or on the enrollment day as per routine clinical practice. | ||||||||
| Condition | CLL | ||||||||
| Intervention | Other: Standard of Care
Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 12 months.
|
||||||||
| Study Groups/Cohorts | Single Group Study. Patients with CLL receiving ibrutinib.
In this study the investigator does not assign specific interventions to the study participants. Participants will receive interventions as part of routine medical care, and the investigator will observe the effect of the intervention. This study will collect prospective real-world data to describe the quality of life (QOL) in patients with CLL receiving ibrutinib in routine Argentinian clinical practice over a 12-month follow-up period. The primary data source for this observational study will be the medical records of each enrolled patient, as well as questionnaires concerning quality of life. Data will be collected at baseline and on months 1,3,6 and 12 during a prospective period. Intervention: Other: Standard of Care
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
50 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 15, 2021 | ||||||||
| Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | Argentina | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04016636 | ||||||||
| Other Study ID Numbers | QOL-Fundaleu0819 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mela Osorio Maria Jose, Fundaleu | ||||||||
| Study Sponsor | Mela Osorio Maria Jose | ||||||||
| Collaborators | Janssen-Cilag Ltd. | ||||||||
| Investigators |
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| PRS Account | Fundaleu | ||||||||
| Verification Date | October 2020 | ||||||||
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