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

Sponsor
Groupe Hospitalier de Bretagne Sud (Other)
Overall Status
Recruiting
CT.gov ID
NCT05910229
Collaborator
(none)
120
1
2
27
4.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Phone call
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
comparative monocentric study with randomisation between two parallel armscomparative monocentric study with randomisation between two parallel arms
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
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.
Actual Study Start Date :
Nov 7, 2022
Anticipated Primary Completion Date :
May 7, 2024
Anticipated Study Completion Date :
Feb 7, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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. [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.

Secondary Outcome Measures

  1. Assess the impact of a telephone call upstream of the simulation scanner on patient preparation according to recommendations. [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.

  2. 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. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital du Scorff Lorient Bretagne France 56100

Sponsors and Collaborators

  • Groupe Hospitalier de Bretagne Sud

Investigators

  • Principal Investigator: Rosalie GUEGAN, GHBretagne sud

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rosalie Guegan, Principal Investigator, Groupe Hospitalier de Bretagne Sud
ClinicalTrials.gov Identifier:
NCT05910229
Other Study ID Numbers:
  • 56LORC_2021_RTEPROST
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rosalie Guegan, Principal Investigator, Groupe Hospitalier de Bretagne Sud
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023