Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
ART-THERAPIE
1 other identifier
interventional
322
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jul 2010
Typical duration for phase_2 breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 5, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 14, 2017
March 1, 2017
4.8 years
April 5, 2011
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
up to 12 months after radiotherapy
Secondary Outcomes (6)
Evaluate the quality of life patients.
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
up to 12 months after radiotherapy
Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients
6 months and 12 months after treatment
Evaluate the anxiety of patients
up 12 months after radiotherapy
evaluate the depression of patients
up 12 months after study
- +1 more secondary outcomes
Study Arms (2)
ART-THERAPIE
EXPERIMENTALsupported in art therapy with other supportive care available in the facility
standard group
NO INTERVENTIONstandard care (supportive care available in each facility)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Metastatic Breast Cancer
- Personal history of breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- Ligue contre le cancer, Francecollaborator
Study Sites (6)
Centre François BACLESSE
Caen, Calvados, 14076, France
CHU
Grenoble, Isère, 38000, France
Centre Oscar LAMBRET
Lille, Nord, 59000, France
Centre Henri Becquerel
Rouen, Seine Maritime, 76 000, France
Centre Antoine LACASSAGNE
Nice, 06, France
Institut Jean Godinot
Reims, 51726, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2011
First Posted
April 8, 2011
Study Start
July 1, 2010
Primary Completion
May 1, 2015
Study Completion
September 1, 2016
Last Updated
March 14, 2017
Record last verified: 2017-03