NCT02858063

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

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
• Phase: —
• Study type: Observational
• Enrollment: 1,045 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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-demographic 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

Conditions

• Breast Cancer

Timeline

• Start date: 2010-01-11
• Primary completion: 2012-04-01
• Completion: 2013-11-27
• First posted: 2016-08-08
• Last updated: 2026-03-16

Locations

25 sites across 1 country: France