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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00210145
Other study ID # IB2003-22
Secondary ID ASE K SEIN
Status Completed
Phase N/A
First received September 13, 2005
Last updated December 29, 2011
Start date October 2003
Est. completion date June 2006

Study information

Verified date October 2007
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast cancer.Two groups of randomized subjects were constituted. Patients of the experimental group received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the control group not. Body image, quality of life and diverse other personality variables were assessed at three different times: surgical operation day before, exit day before of hospitalization and three months afterwards. Our general hypothesis is that subjects who receive aesthetic care report levels significantly higher of corporal satisfaction and of quality of life at the end of the hospitalization and three months later than patients of the control group.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 75 Years
Eligibility Inclusion criteria:

First diagnosis of cancer and first surgical treatment for cancer Diagnosis of breast cancer

Exclusion criteria:

Psychiatric antecedents Inclusion in another psychosocial research

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Aesthetic care


Locations

Country Name City State
France Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

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