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

March 12, 2026 updated by: Centre Oscar Lambret

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

  • 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

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

1045

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Arras, France, 62000
        • Centre Marie Curie
      • Beuvry, France, 62660
        • Centre Pierre Curie
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Croix, France, 59963
        • Clinique du Parc
      • Dechy, France, 59187
        • Centre Leonard de Vinci
      • Dunkirk, France, 59240
        • Centre d'Oncologie Dunkerquois
      • Helfaut, France, 62570
        • Centre Hospitalier de Saint Omer
      • Le Chesnay, France, 78150
        • Hôpital à Mignot
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59000
        • Centre Bourgogne
      • Lille, France, 59020
        • Groupe Hospitalier de l'Institut Catholique de Lille
      • Marcq-en-Barœul, France, 59700
        • Collège des Gynécologues
      • Marseille, France, 13385
        • Service du Pr FAVRE - Hôpital de la TIMONE
      • Maubeuge, France, 59600
        • Centre Gray
      • Montbéliard, France, 25200
        • C.H.B.M.
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Reims, France, 51100
        • Institut du Cancer Courlancy Reims
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Herblain, France, 44805
        • Centre René Gauducheau
      • Saint-Martin-Boulogne, France, 62280
        • Centre Joliot Curie
      • Tourcoing, France, 59200
        • Clinique de la Victoire
      • Valenciennes, France, 59300
        • Clinique des dentellières
      • Vandœuvre-lès-Nancy, France, 54500
        • Centre Alexis Vautrin
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Young women (<45 years old)treated or previously treated by chemotherapy for a non metastatic breast cancer, in Relationship for at least 6 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pending chemotherapy +/- trastuzumab
In the 1st group (chemotherapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending trastuzumab +/- hormone therapy
In the 2nd group (trastuzumab), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending hormone therapy alone
In the third group (hormone therapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending aftercare period
In the last group (aftercare), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychometric validation of a questionnaire in Young patients and their partners
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

Université Lille 3

Investigators

  • Principal Investigator: Laurence VANLEMMENS, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

November 27, 2013

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimated)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KALICOU2-0909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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