Skip to main content
OpenTrials
Completed

NCT Number: NCT01331629

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Fatigue Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre François BACLESSE, Caen, Calvados, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ART-THERAPIE

Other

8 sessions of art therapy during radiotherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluate the quality of life patients.

    Time frame: up to 12 months after radiotherapy

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

  2. 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)

  3. 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)

  4. Evaluate the anxiety of patients

    Time frame: up 12 months after radiotherapy

    Evaluate the anxiety of patients (by auto-questionnary)

  5. evaluate the depression of patients

    Time frame: up 12 months after study

    evaluate the depression of patients (by auto-questionnary)

  6. 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)

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Ligue contre le cancer, France

Registry information

Acronym: ART-THERAPIE

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Apr 8, 2011
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.