ENESTPath Patient's Voice Italian Substudy [Italy]
ENESTPath Patient's Voice Italian Substudy
CML patient's voice: A pilot sub-study exploring the emotional experience of patients during CAMN107AIC05 Study - Italian substudy of ENESTPath (clinicaltrials.gov NCT01743989, EudraCT 2012-005124-15)
Indication and most important inclusion criteria
Patients in consolidation study phase of ENESTPath who will perform visit 6 at the time of sub-study activation
Short description of intervention
Patients from Italian centres participating in ENESTPath will undergo specific Quality of Life and psychological assessments during the consolidation and treatment-free remission phase.
The following tools will be used:
- Patient Diary
- EORTC QLQW-C30: a questionnaire to assess the quality of life of cancer patients
- EORTC-CML: a questionnaire to assess the quality of life of CML patients
- Sixteen Personality Factor Questionnaire (16PF): a self-report personality test;
- Symptom Checklist 90 (SCL.90-R): a self reported questionnaire
Type of study
5. Treatment discontinuation trials
In a single country
Starting to obtain Ethics Committee approvals
Scientific lead / contact
Claudia Galimberti Novartis Farma S.p.A.
Luca Dezzani Novartis Farma S.p.A.
Study centers / principal investigators
Italian centers participating in ENESTPath