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

June 1, 2015 updated by: Institut de Cancérologie de la Loire
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Chu Saint-Etienne
      • Saint-Priest-en-Jarez, France, 42270
        • Institut de Cancérologie de la Loire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: therapeutic education program
patients attend three sessions of therapeutic education
Behavioral: therapeutic education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who refused to participate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients in all sessions
Time Frame: 6 months
6 months
Number of withdrawals
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Investigators

  • Principal Investigator: Jean-Etienne Terrier, MD, Chu Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-04 (BOOG)
  • 2013-A01169-36 (Other Identifier: Agence Nationale de Sécurité du Médicament)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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