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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02858063
• Lead Sponsor: Centre Oscar Lambret

Brief 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

Detailed 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 Timeline

• Study Start: 2010-01
• Primary Completion: 2012-04
• Study Completion: 2012-07
• Status Verified: 2016-08
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Study First Posted: 2016-08-08
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1045

Inclusion Criteria

• >18 years old (patient and partner)
• <45 years old (patient)
• Patient with a non metastatic breast cancer
• Patient treated or previously treated by chemotherapy
• Patient and her Partner live together for at least 6 months when they complete the questionnaires.

Exclusion Criteria

• Patient or patner with psychiatric trouble
• Native language other than french

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
psychometric validation of a questionnaire in Young patients and their partners	1 year

Secondary Outcome Measures

Name	Time	Method
compare convergent and or divergent dimensions with patients and theirs partners	1 year
compare responses of participants according to traitement/ surveillance period	1 year