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NCT01661816 Clinical Trial

Breast Cancer and Quality of Life

Breast Cancer Clinical Trial

— KALICOU  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01661816
Other study ID # KALICOU
Secondary ID
Status Completed
Phase N/A
First received August 2, 2012
Last updated August 7, 2012
Start date April 2007
Est. completion date June 2008

Study information
Verified date August 2012
Source Centre Oscar Lambret
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 171
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- age < 45

- non metastatic breast cancer

- at least 6 months of relationship

Exclusion Criteria:

- no life partner

- inclusion criteria failure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• interview
psychological, emotional, family and social parameters

Locations
Country Name City State
France François Baclesse Center Caen
France Oscar Lambret Center Lille
France Gustave Roussy Institut Paris
France Hospital Valenciennes

Sponsors (1)
Lead Sponsor Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary quality of life at different time of medical follow up 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 No
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