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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 François 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 Eugene Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Herblain, France, 44805
        • Centre Rene Gauducheau
      • Saint-Martin-Boulogne, France, 62280
        • Centre Joliot Curie
      • Tourcoing, France, 59200
        • Clinique de la Victoire
      • Valenciennes, France, 59300
        • Clinique des Dentellieres
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Psychometric validation of a questionnaire in Young patients and their partners
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Oscar Lambret

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Université Lille 3

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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