Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Other: HRQOL Survey Packet
- Registration Number
- NCT00896129
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 448
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study population HRQOL Survey Packet -
- Primary Outcome Measures
Name Time Method 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. By the end of the study.
- Secondary Outcome Measures
Name Time Method Psychological wellbeing. By the end of the study. Fatigue. By the end of the study. Symptom burden. By the end of the study. Adherence to therapy issues. By the end of the study. Possible association between socio-demographic and clinical variables with patient reported health outcomes. By the end of the study.
Trial Locations
- Locations (25)
Università di Pisa, Azienda Ospedaliera Pisana
🇮🇹Pisa, Italy
Policlinico G.B. Rossi
🇮🇹Verona, Italy
Azienda Ospedaliera Pugliese Ciaccio
🇮🇹Catanzaro, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"
🇮🇹Napoli, Italy
Nuovo ospedale "Torrette"
🇮🇹Ancona, Italy
Unità Operativa Ematologica - Università degli Studi di Bari
🇮🇹Bari, Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
🇮🇹Bologna, Italy
Ospedale Ferrarotto
🇮🇹Catania, Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
🇮🇹Ferrara, Italy
Clinica Ematologica - Università degli Studi
🇮🇹Genova, Italy
Ematologia 1 - Centro Trapianto di Midollo
🇮🇹Milano, Italy
Ospedale S. Luigi Gonzaga
🇮🇹Orbassano, Italy
Ospedale Cervello
🇮🇹Palermo, Italy
Azienda ASL di Pescara
🇮🇹Pescara, Italy
Ospedale S.Maria delle Croci
🇮🇹Ravenna, Italy
Università La Sapienza
🇮🇹Roma, Italy
Ospedali Riuniti - Div. di Ematologia
🇮🇹Reggio Calabria, Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
🇮🇹Sassari, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
🇮🇹Roma, Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Azienda USL 9 Treviso - U.O. di Ematologia
🇮🇹Treviso, Italy
Ospedali Riuniti
🇮🇹Bergamo, Italy
Azienda ASL di Cagliari
🇮🇹Cagliari, Italy
Sezione di Ematologia e Trapianti Spedali Civili
🇮🇹Brescia, Italy