Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: therapeutic education program

• Registration Number: NCT02460549
• Lead Sponsor: Institut de Cancérologie de la Loire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-15
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-05
• Study First Submitted QC: 2015-06-01
• Last Update Submitted: 2015-06-01
• Study First Posted: 2015-06-02
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapeutic education program	therapeutic education program	patients attend three sessions of therapeutic education

Primary Outcome Measures

Name	Time	Method
Number of patients who refused to participate	6 months

Secondary Outcome Measures

Name	Time	Method
Number of patients in all sessions	6 months
Number of withdrawals	6 months

Trial Locations

Locations (2)

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France

Institut de Cancérologie de la Loire; 🇫🇷 Saint-Priest-en-Jarez, France