An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01395615
First received: July 14, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
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Purpose
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.
| Condition |
|---|
|
Lymphocytic Leukemia, Chronic |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Quality of life: EuroQol Group EQ-5D questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | October 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with chronic lymphocytic leukaemia
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395615
Locations
| United Kingdom | |
| Bournemouth, United Kingdom, BH7 7DW | |
| Leeds, United Kingdom, LS9 7TF | |
| London, United Kingdom, SE5 9RS | |
| London, United Kingdom, EC1 A7BE | |
| Taunton, United Kingdom, TA1 5DA | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01395615 History of Changes |
| Other Study ID Numbers: | ML22686 |
| Study First Received: | July 14, 2011 |
| Last Updated: | July 14, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Chronic Disease Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013