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
1 other identifier
observational
34
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2008
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 15, 2011
CompletedNovember 2, 2016
November 1, 2016
1 year
July 14, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
Cohort
Eligibility Criteria
Patients with chronic lymphocytic leukaemia
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Bournemouth, BH7 7DW, United Kingdom
Unknown Facility
Leeds, LS9 7TF, United Kingdom
Unknown Facility
London, EC1A 7BE, United Kingdom
Unknown Facility
London, SE5 9RS, United Kingdom
Unknown Facility
Taunton, TA1 5DA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 15, 2011
Study Start
October 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
November 2, 2016
Record last verified: 2016-11