ENESTPath Patient’s Voice Italian Substudy [Italy]

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

Type of study

Treatment discontinuation trials

Current status

No longer recruiting

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

Novartis

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