Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01331629
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Primary Completion: 2015-05
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 322

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
evaluate persistent fatigue	up to 12 months after radiotherapy	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

Name	Time	Method
Evaluate the quality of life patients.	up to 12 months after radiotherapy	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	up to 12 months after radiotherapy	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	6 months and 12 months after treatment	Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients (by auto-questionnary)
Evaluate the anxiety of patients	up 12 months after radiotherapy	Evaluate the anxiety of patients (by auto-questionnary)
evaluate the depression of patients	up 12 months after study	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	6 months and 1 year after treatment	Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients (by auto-questionnary)

Trial Locations

Locations (6)

Centre François BACLESSE; 🇫🇷 Caen, Calvados, France

CHU; 🇫🇷 Grenoble, Isère, France

Centre Oscar LAMBRET; 🇫🇷 Lille, Nord, France

Centre Henri Becquerel; 🇫🇷 Rouen, Seine Maritime, France

Centre Antoine LACASSAGNE; 🇫🇷 Nice, France

Institut Jean Godinot; 🇫🇷 Reims, France