NCT01510964

The Involvement of Breast Cancer Patients During Oncological Consultations

The Involvement of Breast Cancer Patients During Oncological Consultations. A Multi-centre Randomized Controlled Trial. The Study Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study is to assess if a pre consultation intervention facilitates greater participation of patients (and accompanying key persons when present) in the consultation process by determining an increase in questioning and/or in the number of different illness related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist. Other aims are to assess the effect of the intervention on the oncologist's level of patient involvement, on patient satisfaction and coping and to explore the role of key persons accompanying the patient. The investigators expect that patients who have the opportunity to rehearse their informative needs before the consultation will ask a greater number of questions which in turn will determine their greater involvement by the physician and a greater number of satisfied needs. The investigators expect also that the straightforward use of a list of printed questions of potential relevance for cancer patients and their companions at an early stage of illness, by modifying the process of information exchange, increases their participation and satisfaction with the consultation, with potential benefits for treatment adherence and consequently treatment efficacy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	prompt-sheet	Prompt sheet is a form on which to write the reply to the following request: "Please indicate the arguments which you want to discuss today with your oncologist" and a written list of possible questions the patient (companion) would like to ask to the oncology.
BEHAVIORAL	control group	Patients and companions of the control group receive a form on which to write their reply to the following request: "Please indicate the arguments which you want to discuss today with your oncologist"

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-01-18
• Last updated: 2013-08-13

Locations

1 site across 1 country: Italy