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.
Verified February 2012 by Centre Francois Baclesse
Sponsor:
Centre Francois Baclesse
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, 2013
Last verified: February 2012
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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
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: Louis GRAS, MD | |
| Sub-Investigator: Sylvain DEWAS, MD | |
| Principal Investigator: Louis GRAS, MD | |
| Sub-Investigator: David PASQUIER, MD | |
| Sub-Investigator: Claire DEWAS VAUTRAVERS, MD | |
| Sub-Investigator: Florence LE TINIER, 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 | |
| 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, 2013 |
| 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:
|
Breast Neoplasms Fatigue Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Signs and Symptoms Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013