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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ART-THERAPIE
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, fatigue, quality of life, art-therapie, adjuvant radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre François BACLESSE
  • CHU
  • Centre Oscar LAMBRET
  • Centre Henri Becquerel
  • Centre Antoine LACASSAGNE
  • Institut Jean Godinot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ART-THERAPIE

standard group

Arm Description

supported in art therapy with other supportive care available in the facility

standard care (supportive care available in each facility)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the quality of life patients.
Evaluate the quality of life patients (by auto-questionnary)
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)
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)
Evaluate the anxiety of patients
Evaluate the anxiety of patients (by auto-questionnary)
evaluate the depression of patients
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
Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients (by auto-questionnary)

Full Information

First Posted
April 5, 2011
Last Updated
March 13, 2017
Sponsor
Centre Francois Baclesse
Collaborators
Ligue contre le cancer, France
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1. Study Identification

Unique Protocol Identification Number
NCT01331629
Brief Title
Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
Acronym
ART-THERAPIE
Official Title
Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Ligue contre le cancer, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, fatigue, quality of life, art-therapie, adjuvant radiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ART-THERAPIE
Arm Type
Experimental
Arm Description
supported in art therapy with other supportive care available in the facility
Arm Title
standard group
Arm Type
No Intervention
Arm Description
standard care (supportive care available in each facility)
Intervention Type
Other
Intervention Name(s)
ART-THERAPIE
Intervention Description
8 sessions of art therapy during radiotherapy
Primary Outcome Measure Information:
Title
evaluate persistent fatigue
Description
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 Outcome Measure Information:
Title
Evaluate the quality of life patients.
Description
Evaluate the quality of life patients (by auto-questionnary)
Time Frame
up to 12 months after radiotherapy
Title
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
Description
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
Title
Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients
Description
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
Title
Evaluate the anxiety of patients
Description
Evaluate the anxiety of patients (by auto-questionnary)
Time Frame
up 12 months after radiotherapy
Title
evaluate the depression of patients
Description
evaluate the depression of patients (by auto-questionnary)
Time Frame
up 12 months after study
Title
Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients
Description
Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients (by auto-questionnary)
Time Frame
6 months and 1 year after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre François BACLESSE
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
CHU
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38000
Country
France
Facility Name
Centre Oscar LAMBRET
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
State/Province
Seine Maritime
ZIP/Postal Code
76 000
Country
France
Facility Name
Centre Antoine LACASSAGNE
City
Nice
ZIP/Postal Code
06
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51726
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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