Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer (ART-THERAPIE)

March 13, 2017 updated by: Centre Francois Baclesse
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06
        • Centre Antoine Lacassagne
      • Reims, France, 51726
        • Institut Jean Godinot
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre Francois Baclesse
    • Isère
      • Grenoble, Isère, France, 38000
        • CHU
    • Nord
      • Lille, Nord, France, 59000
        • Centre Oscar Lambret
    • Seine Maritime
      • Rouen, Seine Maritime, France, 76 000
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the quality of life patients.
Time Frame: up to 12 months after radiotherapy
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
Time Frame: 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)
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 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
Time Frame: up 12 months after radiotherapy
Evaluate the anxiety of patients (by auto-questionnary)
up 12 months after radiotherapy
evaluate the depression of patients
Time Frame: up 12 months after study
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
Time Frame: 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)
6 months and 1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

Ligue contre le cancer, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimate)

April 8, 2011

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-THERAPIE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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