Telephone Paramedical Support Prior to the Radiotherapy Simulation Scanner for Patients With Prostate Cancer (RTEPROST)

February 22, 2024 updated by: Rosalie Guegan, Groupe Hospitalier de Bretagne Sud

Interest of a Telephone Paramedical Support Prior to the Radiotherapy Simulation Scanner to Ensure the Realization of Specific Recommendations for the Management of Patients With Prostate Cancer.

The goal of this clinical trial is to evaluate the impact of a phone call before the simulation CT scan in management of care of patients with prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study, all patients who have given written informed consent and who met eligibility requirement will be randomized in a simple blind manner ( investigator) in a 1:1 ration.

The main question it aims to answer is : Does a phone call before the simulation CT scan has an effectiveness on patients compliance of the recommendations and therefore on obtaining quality images.

There is no additional risk of patients involvement.

Study Type

Interventional

Enrollment (Estimated)

120

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 Contact

Study Locations

  • France
    • Bretagne
      • Lorient, Bretagne, France, 56100
        • Recruiting
        • Hôpital du Scorff
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult
  • Patient coming for prostate cancer treatment with or without lymph node irradiation
  • Minimum of 48 hours between the onco radiotherapist and the CT scan
  • Signed a written informed consent form
  • Affiliated to the social security system

Exclusion Criteria:

  • Patient not understanding French
  • Patient not reachable by phone
  • Individual of full age deprived of liberty or placed under a legal protection measure

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Patient with standard care
Consultation with the onco radiotherapeutic and submission of the recommendations to follow before the simulation CT Scan before the radiotherapy
Experimental: Patient with personalized support
Consultation with the onco radiotherapeutic and submission of the recommendations to follow before the simulation CT Scan before the radiotherapy and a phone call by a radiotherapy technician
Other: Phone call
In the experimental arm the patient will be called 3 days before the CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the value of a telephone call in terms of compliance recommendations for preparation (empty rectum and full bladder) necessary to perform the CT scanner simulation in the management of patients with prostate cancer.
Time Frame: From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
The proportion of patients for whom it is necessary to renew the CT scanner simulation.
From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the impact of a telephone call upstream of the simulation scanner on patient preparation according to recommendations.
Time Frame: From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
The number of patients who performed the preparation for the scanner.
From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
Assess the impact of a telephone call upstream of the simulation scanner on reading the recommendation sheet given to the patient during the announcement medical consultation.
Time Frame: From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
The number of patients who read the recommendations
From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier de Bretagne Sud

Investigators

  • Principal Investigator: Rosalie GUEGAN, GHBretagne sud

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 (Actual)

November 9, 2022

Primary Completion (Estimated)

November 9, 2024

Study Completion (Estimated)

March 9, 2025

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56LORC_2021_RTEPROST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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