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

NCT ID: NCT01331629

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ART-THERAPIE

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

Group Type EXPERIMENTAL

ART-THERAPIE

Intervention Type OTHER

8 sessions of art therapy during radiotherapy

standard group

standard care (supportive care available in each facility)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ART-THERAPIE

8 sessions of art therapy during radiotherapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre François BACLESSE

Caen, Calvados, France

Site Status

CHU

Grenoble, Isère, France

Site Status

Centre Oscar LAMBRET

Lille, Nord, France

Site Status

Centre Henri Becquerel

Rouen, Seine Maritime, France

Site Status

Centre Antoine LACASSAGNE

Nice, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Countries

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France

Other Identifiers

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ART-THERAPIE

Identifier Type: -

Identifier Source: org_study_id

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