Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment art-therapie
Phase phase 2/phase 3
Sponsor Centre Francois Baclesse
Collaborator Ligue contre le cancer, France
Start date July 2010
End date May 2015
Trial size 322 participants
Trial identifier NCT01331629, ART-THERAPIE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
supported in art therapy with other supportive care available in the facility
art-therapie
8 sessions of art therapy during radiotherapy
(No Intervention)
standard care (supportive care available in each facility)

Primary Outcomes

Measure
evaluate persistent fatigue
time frame: up to 12 months after radiotherapy

Secondary Outcomes

Measure
Evaluate the quality of life patients.
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
time frame: up to 12 months after radiotherapy
Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients
time frame: 6 months and 12 months after treatment
Evaluate the anxiety of patients
time frame: up 12 months after radiotherapy
evaluate the depression of patients
time frame: up 12 months after study
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Francois Baclesse.