Breast Cancer Clinical Trial
— ART-THERAPIEOfficial title:
Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
| Verified date | March 2017 |
| Source | Centre Francois Baclesse |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 322 |
| Est. completion date | September 2016 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre François BACLESSE | Caen | Calvados |
| France | CHU | Grenoble | Isère |
| France | Centre Oscar LAMBRET | Lille | Nord |
| France | Centre Antoine LACASSAGNE | Nice | |
| France | Institut Jean Godinot | Reims | |
| France | Centre Henri Becquerel | Rouen | Seine Maritime |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Francois Baclesse | Ligue contre le cancer, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Evaluate the quality of life patients. | Evaluate the quality of life patients (by auto-questionnary) | up to 12 months after radiotherapy | |
| Secondary | 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) | up to 12 months after radiotherapy | |
| Secondary | 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) | 6 months and 12 months after treatment | |
| Secondary | Evaluate the anxiety of patients | Evaluate the anxiety of patients (by auto-questionnary) | up 12 months after radiotherapy | |
| Secondary | evaluate the depression of patients | evaluate the depression of patients (by auto-questionnary) | up 12 months after study | |
| Secondary | 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) | 6 months and 1 year after treatment |
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