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

Centre Francois Baclesse322 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

322

Conditions

Breast Cancer

Interventions

ART-THERAPIEOTHER

8 sessions of art therapy during radiotherapy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Time frame: up to 12 months after radiotherapy

Secondary Outcomes

Evaluate the quality of life patients.

Evaluate the quality of life patients (by auto-questionnary)

Time frame: 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)

Time frame: 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)

Time frame: 6 months and 12 months after treatment

Evaluate the anxiety of patients

Evaluate the anxiety of patients (by auto-questionnary)

Time frame: up 12 months after radiotherapy

evaluate the depression of patients

evaluate the depression of patients (by auto-questionnary)

Time frame: up 12 months after study

Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients

Data from ClinicalTrials.gov

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