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

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.

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Key information

Conditions

Lymphocytic Leukemia, Chronic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bournemouth, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Quality of life: EuroQol Group EQ-5D questionnaire

Time frame: 18 months
Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

Time frame: 18 months
Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire

Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jul 15, 2011
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed