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Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer. (ASE K SEIN)

This study has been completed.
Sponsor:
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210145
First received: September 13, 2005
Last updated: December 29, 2011
Last verified: October 2007
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Behavioral: Aesthetic care

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Impact of a Socio-aesthetic Intervention on Body Image and Quality of Life in Patients With Mastectomy or Tumorectomy for Breast Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Bergonié:

Estimated Enrollment: 100
Study Start Date: October 2003
Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210145

Locations
France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Fabrice LAKDJA, MD Institut Bergonié
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210145     History of Changes
Other Study ID Numbers: IB2003-22, ASE K SEIN
Study First Received: September 13, 2005
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Aesthetic care,
Mastectomy,
Breast cancer,
 Quality of life,
Body image,
Psychological adjustment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013