ENESTPath Patient’s Voice Italian Substudy [Italy]

Type of study

Treatment discontinuation trials

Current status

No longer recruiting

Study title

ENESTPath Patient’s Voice Italian Substudy

Scientific title

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

What is the purpose of the study

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

Key inclusion criteria

Patients in consolidation study phase of ENESTPath who will perform visit 6 at the time of sub-study activation

Key exclusion criteria

Where can I find additional information

Study sponsor


Scientific lead / contact

Claudia Galimberti Novartis Farma S.p.A.

Principal investigator

Luca Dezzani Novartis Farma S.p.A.

Study centers / principal investigators

Italian centers participating in ENESTPath