An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia

Completed

• Conditions: Lymphocytic Leukemia, Chronic

• Registration Number: NCT01395615
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life: EuroQol Group EQ-5D questionnaire	18 months
Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire	18 months
Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire	18 months