Clinical trial · Observational
An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia
Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia
NCT01395615CI-TRIAL-00024632completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This observational study will assess the health related quality of life (HQRL) profiles of patients with chronic lymphocytic leukaemia. Using health assessment questionnaires, data will be collected from patients currently receiving therapy and from those who have finished therapy and have undergone an assessment of treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort
Primary outcomes (3)
- measure
- Quality of life: EuroQol Group EQ-5D questionnaire
- timeFrame
- 18 months
- measure
- Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
- timeFrame
- 18 months
- measure
- Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Patients with chronic lymphocytic leukaemia * Patients receiving 1st line therapy * Patients receiving 2nd line therapy. This will include patients who previously have responded well to 1st line therapy (relapse was \>12 months after finishing the 1st line therapy) and are receiving the same therapy again * Within the past three months, patients whose treatment has been stopped after 2-3 cycles of 1st or 2nd line therapy and who have not received any further therapies * Patients receiving their 3rd, 4th, 5th or 6th cycle of 1st or 2nd line therapy * Patients who have completed therapy, are considered stable and are between 3-12 months post therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Exclusion Criteria: * Clinically significant disorder (other than chronic lymphocytic leukaemia and chronic lymphocytic comorbidities) or any other condition, including alcohol or drug abuse, which may interfere with study participation or affect study conclusions * Mental disability or significant mental illness, legal incapacity or limited legal capacity * Current high degree of comorbid burden that might affect the accuracy of the quality of life data
References
Publications (0)
Data not yet available
No reference posted for this study.