Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

number of question during the consultation

Outcome Description:

The intervention prompt-sheet aims to increase the number of question by giving the opportunity to patients and companions to reflect on their informative needs on the basis of a wide range of possible questions from which to choose those perceived as most relevant in view of the subsequent consultation. Question asking is considered an index for patient participation during the consultation. The total number of patient questions during the consultation regarding diagnosis, prognosis, treatment and other issues is the primary outcome measure.

Outcome Time Frame:

1 hour after the intervention (question prompt-sheet)

Safety Issue:

No

Principal Investigator

Claudia Goss

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Verona

Authority:

Scientific Committee: Prof. Christa Zimmermann, Prof. Lidia Del Piccolo

Study ID:

INCA (CE.Prot. 1719)

NCT ID:

NCT01510964

Start Date:

June 2011

Completion Date:

September 2012

Related Keywords:

• Breast Cancer
• Breast cancer
• Patient involvement
• Question prompt-sheet
• Doctor-patient communication
• RCT
• Breast Neoplasms