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Completed

NCT Number: NCT02858063

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

* 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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Marie Curie, Arras, France

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About this study

  • Before consultation :

Selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file

  • 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)
  • 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:
  • They send information note to the medical center
  • They send the questionnaires to the university

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Psychometric validation of a questionnaire in Young patients and their partners

    Time frame: 1 year

Secondary outcomes

  1. Compare convergent and or divergent dimensions with patients and theirs partners

    Time frame: 1 year

  2. Compare responses of participants according to treatment/ surveillance period

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • University Charles-de-Gaulle

Registry information

Official study 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)

Acronym: KALICOU2

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 8, 2016
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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