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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: ART-THERAPIE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ART-THERAPIE<br>supported in art therapy with other supportive care available in the facility | Other: ART-THERAPIE<br>* 8 sessions of art therapy during radiotherapy<br>|
| No Intervention: standard group<br>standard care (supportive care available in each facility) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate persistent fatigue | 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 | up to 12 months after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the quality of life patients. | Evaluate the quality of life patients (by auto-questionnary) | up to 12 months after radiotherapy | 
| 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 | Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives (by auto-questionnary) | up to 12 months after radiotherapy | 
| Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients | Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients (by auto-questionnary) | 6 months and 12 months after treatment | 
| Evaluate the anxiety of patients | Evaluate the anxiety of patients (by auto-questionnary) | up 12 months after radiotherapy | 
| evaluate the depression of patients | evaluate the depression of patients (by auto-questionnary) | up 12 months after study | 
| Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients | Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients (by auto-questionnary) | 6 months and 1 year after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, fatigue, quality of life, art-therapie, adjuvant radiotherapy