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

NCT ID: NCT01395615

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-10-31

Brief Summary

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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

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Conditions

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Lymphocytic Leukemia, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Bournemouth, , United Kingdom

Site Status

Leeds, , United Kingdom

Site Status

London, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Taunton, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ML22686

Identifier Type: -

Identifier Source: org_study_id