Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00896129
First received: May 8, 2009
Last updated: January 21, 2014
Last verified: January 2014

May 8, 2009
January 21, 2014
March 2010
December 2010   (final data collection date for primary outcome measure)
Number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00896129 on ClinicalTrials.gov Archive Site
  • Psychological wellbeing. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Fatigue. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Adherence to therapy issues. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Symptom burden. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Possible association between socio-demographic and clinical variables with patient reported health outcomes. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.

Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib.

Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.

OBJECTIVES:

Primary: to investigate a number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.

Secondary evaluation of:

  • Psychological wellbeing.
  • Fatigue.
  • Adherence to therapy issues.
  • Symptom burden.
  • Possible association between social-demographic and clinical variables with patient reported health outcomes.

OUTLINE:This is a multicenter study.

SAMPLE SIZE:

Sample size estimation has not been performed considering the nature of the study and the lack of preliminary data to hypothesize the number of possible eligible patients in each center.

DURATION OF THE STUDY:

The recruitment period is estimated in approximately 6 to 12 months.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

Adult CML patiens under Imatinib treatment for at least three years

Chronic Myeloid Leukemia
Other: HRQOL Survey Packet
Questionnaires
Study population
Intervention: Other: HRQOL Survey Packet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
448
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years.
  • CML patients meeting the following criteria:

    • Started IM therapy in the early chronic phase (ECP).
    • Have been undergoing treatment with IM, as first line therapy, for at least three years regardless of the current prescribed dose of IM.
    • In complete cytogenetic response (CCgR) and no clinical evidence of disease progression to accelerated phase (AP) or blast crisis (BC).
  • Able to read and write Italian.
  • Freedom from psychiatric conditions that may confound HRQOL evaluation.
  • Informed consent provided.

Exclusion Criteria:

  • CML patients who were initially diagnosed in the AP or BC or those who started therapy with IM in the late chronic phase (LCP).
  • Having received any kind of treatment prior to IM therapy (except for hydroxyurea and/or anagrelide).
  • Patients with a new primary malignancy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00896129
QOL-CML0208
No
Gruppo Italiano Malattie EMatologiche dell'Adulto
Gruppo Italiano Malattie EMatologiche dell'Adulto
Not Provided
Study Chair: Fabio Efficace, PhD GIMEMA Foundation
Gruppo Italiano Malattie EMatologiche dell'Adulto
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP