NCT02460549CompletedNot Applicable
Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation
Institut de Cancérologie de la Loire4 sites in 1 country9 target enrollmentStarted: April 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 4
- Primary Endpoint
- Number of patients who refused to participate
Study Overview
Brief Summary
The purpose of the study is to build and assess the feasibility of a therapeutic education program, constructed in collaboration with the urologists of the University Hospital of Saint Etienne. The aim of this therapeutic education program is to delay the onset or to reduce the amplitude of the development of insulin resistance and side effects of androgen deprivation therapy in patients treated with androgen deprivation in the context of an evolutive prostate cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients supported in consultation Urology at the University Hospital North Saint Etienne.
- •Aged over 18 years
- •Having an evolutive prostate cancer
- •Patient treated with LHRH agonist for at least 6 months - Affiliated with the national health insurance system
- •And having completed the worksheet informed consent to participate in the program.
Exclusion Criteria
- •Refusal of participation, protected or under guardianship patients.
- •Patients unable to understand the study or unable to follow the educational sessions.
- •Patient (s) with documented cognitive or psychiatric history.
- •Geographical remotness (more than 100 Kms.)
Outcomes
Primary Outcomes
Number of patients who refused to participate
Time Frame: 6 months
Secondary Outcomes
- Number of patients in all sessions(6 months)
- Number of withdrawals(6 months)
Investigators
Study Sites (4)
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