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ENESTPath Patient's Voice Italian Substudy [Italy]

ENESTPath Patient's Voice Italian Substudy [Italy]

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)

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

Current status

Starting to obtain Ethics Committee approvals

Study sponsor

Novartis

Scientific lead / contact

Claudia Galimberti Novartis Farma S.p.A.

Principal investigator

Luca Dezzani Novartis Farma S.p.A.

Additional information

...

Study centers / principal investigators

Italian centers participating in ENESTPath