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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01331629
• Date of registration: 05/04/2011
• Prospective Registration: No
• Primary sponsor: Centre Francois Baclesse
• Public title: Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer ART-THERAPIE
• Scientific title: Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
• Date of first enrolment: July 2010
• Target sample size: 322
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01331629
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Other: ART-THERAPIE

Primary Outcome(s)

evaluate persistent fatigue [Time Frame: up to 12 months after radiotherapy]

Secondary Outcome(s)

Evaluate the anxiety of patients [Time Frame: up 12 months after radiotherapy]

evaluate the depression of patients [Time Frame: up 12 months after study]

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]

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]

Evaluate the quality of life patients. [Time Frame: up to 12 months after radiotherapy]

Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients [Time Frame: 6 months and 12 months after treatment]

Secondary ID(s)

ART-THERAPIE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ligue contre le cancer, France