Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care
N/A
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Female
Non Metastatic Breast Cancer
Female
Non Metastatic Breast Cancer
Trial Information
Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care
Inclusion Criteria:
- breast cancer
- treatment including a chemotherapy
- in complete remission
- last treatment in the last 9 months before inclusion
- signed consent
Exclusion Criteria:
- metastatic disease
- relapse
- women enable to have physical activity
- heart disease or any pathology preventing physical activity
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Quality of life (SF36)
Outcome Description:
Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.
Outcome Time Frame:
one year after inclusion
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
PACThe
NCT ID:
NCT01563588
Start Date:
May 2008
Completion Date:
October 2013
Related Keywords:
- Non Metastatic Breast Cancer
- breast cancer
- chemotherapy
- first line treatment
- treatments include a chemotherapy
- last treatment not performed more than 9 months earlier
- Breast Neoplasms
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