Trials / Completed
CompletedNCT00896129
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 448 (actual)
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | HRQOL Survey Packet | Questionnaires |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2009-05-11
- Last updated
- 2014-01-22
Locations
25 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00896129. Inclusion in this directory is not an endorsement.