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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02858063

Acronym

KALICOU2

Enrollment

1045

Registered

2016-08-08

Start date

2010-01-11

Completion date

2013-11-27

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Quality Of Life, Women, Partner

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-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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

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 partner with psychiatric trouble * Native language other than french

Design outcomes

Primary

Measure	Time frame
Psychometric validation of a questionnaire in Young patients and their partners	1 year

Secondary

Measure	Time frame
Compare convergent and or divergent dimensions with patients and theirs partners	1 year
Compare responses of participants according to treatment/ surveillance period	1 year

Countries

France

Contacts

PRINCIPAL_INVESTIGATORLaurence VANLEMMENS, MD

Centre Oscar Lambret

Outcome results