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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01331629

Acronym

ART-THERAPIE

Enrollment

322

Registered

2011-04-08

Start date

2010-07-31

Completion date

2016-09-30

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, fatigue, quality of life, art-therapie, adjuvant radiotherapy

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.

Interventions

OTHERART-THERAPIE

8 sessions of art therapy during radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 quality of life patients.	up to 12 months after radiotherapy	Evaluate the quality of life 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)
Evaluate the anxiety of patients	up 12 months after radiotherapy	Evaluate the anxiety of patients (by auto-questionnary)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026