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

Breast Cancer Clinical Trial

— KALICOU2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858063
• Other study ID #: KALICOU2-0909
• Status: Completed
• Phase: N/A
• First received: August 3, 2016
• Last updated: August 3, 2016
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertésFrance: Conseil National de l'Ordre des Médecins
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1045
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Université Lille 3

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychometric validation of a questionnaire in Young patients and their partners		1 year	No
Secondary	compare convergent and or divergent dimensions with patients and theirs partners		1 year	No
Secondary	compare responses of participants according to traitement/ surveillance period		1 year	No