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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01395615
Collaborator
(none)
34
Enrollment
5
Locations
12
Duration (Months)
6.8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    34 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia
    Study Start Date :
    Oct 1, 2008
    Actual Primary Completion Date :
    Oct 1, 2009
    Actual Study Completion Date :
    Oct 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life: EuroQol Group EQ-5D questionnaire [18 months]

    2. Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire [18 months]

    3. Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire [18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Bournemouth United Kingdom BH7 7DW
    2 Leeds United Kingdom LS9 7TF
    3 London United Kingdom EC1A 7BE
    4 London United Kingdom SE5 9RS
    5 Taunton United Kingdom TA1 5DA

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT01395615
    Other Study ID Numbers:
    • ML22686
    First Posted:
    Jul 15, 2011
    Last Update Posted:
    Nov 2, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Nov 2, 2016