Breast Cancer and Quality of Life (KALICOU)

August 7, 2012 updated by: Centre Oscar Lambret

Impact of Breast Cancer on Quality of Life of the Young Women, Her Life Partner and Her Couple

The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

171

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
      • Caen, France
        • Francois Baclesse Center
      • Lille, France, 59 020
        • Oscar Lambret Center
      • Paris, France, 75 005
        • Gustave Roussy Institut
      • Valenciennes, France
        • Hospital

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient with breast cancer, diagnosed before aged 45, having a life partner

Description

Inclusion Criteria:

  • age < 45
  • non metastatic breast cancer
  • at least 6 months of relationship

Exclusion Criteria:

  • no life partner
  • inclusion criteria failure

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
Intervention / Treatment
Within chemotherapy
30 couples, interviewed within chemotherapy (6 to 8 months after diagnosis)
Behavioral: interview
psychological, emotional, family and social parameters
within Herceptin
30 couples, within herceptin treatment (the first year after diagnosis)
Behavioral: interview
psychological, emotional, family and social parameters
within hormonotherapy
30 couples, within hormonotherapy (between 2 and 7 years after diagnosis)
Behavioral: interview
psychological, emotional, family and social parameters
without hormonotherapy
30 couples, did not received hormonotherapy (1 year after diagnosis)
Behavioral: interview
psychological, emotional, family and social parameters
end of treatment
30 couples, after end of treatments for patients who did received hormonotherapy (7 years after diagnosis)
Behavioral: interview
psychological, emotional, family and social parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life at different time of medical follow up
Time Frame: 6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis
interviews with couples at different time frame depending on which group they are in
6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis

Collaborators and Investigators

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

Sponsor

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

April 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KALICOU

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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