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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01395615
First received: July 14, 2011
Last updated: March 2, 2015
Last verified: March 2015
  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: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, EC1A 7BE
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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01395615     History of Changes
Other Study ID Numbers: ML22686
Study First Received: July 14, 2011
Last Updated: March 2, 2015
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 27, 2015