Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner — KALICOU2  

Breast Cancer Clinical Trial

Official title: Psychometric Validation of a Subjective Quality-of-life Scale in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU 2 Protocol)

Status Completed

Clinical Trial Summary

• Selection of patient and preparation of questionnaires

• Presentation of the study by the doctor

• Verbal consent of participants (patient and Partner)

• Delivery of booklets

• Response to documents (questionnaires and written consent) at home, send by mail

Clinical Trial Description

1. Before consultation :

Selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file

2. During the consultation :

• Presentation of the study by the investigator

• The investigator signs the information note and give two file to the patient (1 for her and 1 for her Partner : both contains 1 information note signed by the investigator, 1 questionnaire and 2 stamped envelopes

• Finally, the investigator fill-in the medical form and send the original to the university (université de Lille 3)

3. At home :

• Signature of the information note and the participation consent form

• Patients and Partner responds to their questionnaire (including socio-demographique questionnaire)

• They send the documents thanks to stamped envelopes:

1. They send information note to the medical center

2. They send the questionnaires to the university ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02858063
• Study type: Observational
• Source: Centre Oscar Lambret
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Completion date: July 2012