Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer (ART-THERAPIE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Centre Francois Baclesse
Sponsor:
Collaborator:
Ligue contre le cancer, France
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01331629
First received: April 5, 2011
Last updated: April 18, 2014
Last verified: February 2012
  Purpose

The purpose of this study is to compare intervention by Art-therapy to standard care in patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.


Condition Intervention Phase
Breast Cancer
Other: ART-THERAPIE
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • evaluate persistent fatigue [ Time Frame: up to 12 months after radiotherapy ] [ Designated as safety issue: No ]

    Estimate the decrease in the proportion of patients with persistent fatigue after one month of radiotherapy in patients receiving an approach from art therapy as a complement to standard care compared to those with care standard alone.

    Evaluated by auto-questionnary



Secondary Outcome Measures:
  • Evaluate the quality of life patients. [ Time Frame: up to 12 months after radiotherapy ] [ Designated as safety issue: No ]
    Evaluate the quality of life patients (by auto-questionnary)

  • Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives [ Time Frame: up to 12 months after radiotherapy ] [ Designated as safety issue: No ]
    Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives (by auto-questionnary)

  • Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients [ Time Frame: 6 months and 12 months after treatment ] [ Designated as safety issue: No ]
    Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients (by auto-questionnary)

  • Evaluate the anxiety of patients [ Time Frame: up 12 months after radiotherapy ] [ Designated as safety issue: No ]
    Evaluate the anxiety of patients (by auto-questionnary)

  • evaluate the depression of patients [ Time Frame: up 12 months after study ] [ Designated as safety issue: No ]
    evaluate the depression of patients (by auto-questionnary)

  • Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients [ Time Frame: 6 months and 1 year after treatment ] [ Designated as safety issue: No ]
    Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients (by auto-questionnary)


Estimated Enrollment: 320
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ART-THERAPIE
supported in art therapy with other supportive care available in the facility
Other: ART-THERAPIE
8 sessions of art therapy during radiotherapy
No Intervention: standard group
standard care (supportive care available in each facility)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer surgery (invasive or in situ) by conservative surgery
  • Age ≥ 18 years
  • Indication of adjuvant radiotherapy
  • Adjuvant chemotherapy allowed
  • Agreeing to participate in a clinical study
  • Able to participate in a clinical trial

Exclusion Criteria:

  • Metastatic Breast Cancer
  • Personal history of breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331629

Contacts
Contact: Florence JOLy-LOBBEDEZ, PD 02 31 45 50 02 f.joly@baclesse.fr

Locations
France
Centre François BACLESSE Recruiting
Caen, Calvados, France, 14076
Contact: Florence JOLY-LOBBEDEZ, PD    02 31 45 50 02    f.joly@baclesse.fr   
Sub-Investigator: Sabine NOAL, MD         
Sub-Investigator: Christelle LEVY, MD         
Principal Investigator: Florence JOLY-LOBBEDEZ, PD         
Sub-Investigator: Corinne DELCAMBRE, MD         
Sub-Investigator: Odile SWITSERS, MD         
Sub-Investigator: Djelila ALLOUACHE, MD         
Sub-Investigator: Jean-Michel OLLIVIER, MD         
Sub-Investigator: Alain RIVIERE, MD         
Sub-Investigator: Pascaline BERTHET, MD         
Sub-Investigator: Julien GEFFRELOT, MD         
Sub-Investigator: Ioana HRAB, MD         
CHU Recruiting
Grenoble, Isère, France, 38000
Contact: Mireille MOUSSEAU, MD         
Principal Investigator: Mireille MOUSSEAU, MD         
Sub-Investigator: Mathieu LARAMAS, MD         
Sub-Investigator: Cristina COSTAN, MD         
Sub-Investigator: Isabelle GABELLE-FLANDIN, MD         
Centre Oscar LAMBRET Recruiting
Lille, Nord, France, 59000
Contact: Florence LE TINIER, MD         
Sub-Investigator: Sylvain DEWAS, MD         
Principal Investigator: Louis GRAS, MD         
Sub-Investigator: David PASQUIER, MD         
Sub-Investigator: Claire DEWAS VAUTRAVERS, MD         
Sub-Investigator: Xavier LIEM, MD         
Centre Henri Becquerel Recruiting
Rouen, Seine Maritime, France, 76 000
Contact: Chantal HANZEN, MD         
Principal Investigator: Chantal HANZEN, MD         
Sub-Investigator: Olivier RIGAL, MD         
Centre Antoine LACASSAGNE Not yet recruiting
Nice, France, 06
Contact: Catherine CIAIS, MD         
Principal Investigator: Catherine CIAIS, MD         
Sub-Investigator: Anne FOGLIARINI, MD         
Sub-Investigator: Véronique MARI, MD         
Sub-Investigator: Marie-Eve CHAND-FOUCHE, MD         
Institut Jean Godinot Not yet recruiting
Reims, France, 51726
Contact: Sophie MAILLARD, MD         
Principal Investigator: Sophie MAILLARD, MD         
Sub-Investigator: Philippe GUILBERT, MD         
Sub-Investigator: Tan Dat N'GUYEN, MD         
Sub-Investigator: Aurélie FADIN, MD         
Sub-Investigator: Carmen MURARIU, MD         
Sponsors and Collaborators
Centre Francois Baclesse
Ligue contre le cancer, France
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01331629     History of Changes
Other Study ID Numbers: ART-THERAPIE
Study First Received: April 5, 2011
Last Updated: April 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
breast cancer
fatigue
quality of life
art-therapie
adjuvant radiotherapy

Additional relevant MeSH terms:
Fatigue
Breast Neoplasms
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014