A Study to Evaluate Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia
- Conditions
- CLL
- Interventions
- Other: Standard of Care
- Registration Number
- NCT04016636
- Lead Sponsor
- Mela Osorio Maria Jose
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- Pregnant and breast-feeding patients
- Impairment of ingestion and/or absorption of ibrutinib
- Mental or physical limitation to complete the QoL questionnaires.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single Group Study. Patients with CLL receiving ibrutinib. Standard of Care 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.
- Primary Outcome Measures
Name Time Method Change From Baseline 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.
- Secondary Outcome Measures
Name Time Method Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L) 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.
Trial Locations
- Locations (1)
Fundaleu
🇦🇷Buenos Aires, Argentina