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

Primary Purpose

Radiotherapy, Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phone call
Sponsored by
Groupe Hospitalier de Bretagne Sud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Radiotherapy focused on measuring paramedical phone call

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital du ScorffRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Patient with standard care

Patient with personalized support

Arm Description

Consultation with the onco radiotherapeutic and submission of the recommendations to follow before the simulation CT Scan before the radiotherapy

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

Outcomes

Primary Outcome Measures

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.
The proportion of patients for whom it is necessary to renew the CT scanner simulation.

Secondary Outcome Measures

Assess the impact of a telephone call upstream of the simulation scanner on patient preparation according to recommendations.
The number of patients who performed the preparation for the scanner.
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.
The number of patients who read the recommendations

Full Information

First Posted
May 5, 2023
Last Updated
June 15, 2023
Sponsor
Groupe Hospitalier de Bretagne Sud
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1. Study Identification

Unique Protocol Identification Number
NCT05910229
Brief Title
Telephone Paramedical Support Prior to the Radiotherapy Simulation Scanner for Patients With Prostate Cancer
Acronym
RTEPROST
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
May 7, 2024 (Anticipated)
Study Completion Date
February 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier de Bretagne Sud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy, Prostate Cancer
Keywords
paramedical phone call

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparative monocentric study with randomisation between two parallel arms
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with standard care
Arm Type
No Intervention
Arm Description
Consultation with the onco radiotherapeutic and submission of the recommendations to follow before the simulation CT Scan before the radiotherapy
Arm Title
Patient with personalized support
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Phone call
Intervention Description
In the experimental arm the patient will be called 3 days before the CT scan
Primary Outcome Measure Information:
Title
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.
Description
The proportion of patients for whom it is necessary to renew the CT scanner simulation.
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
Secondary Outcome Measure Information:
Title
Assess the impact of a telephone call upstream of the simulation scanner on patient preparation according to recommendations.
Description
The number of patients who performed the preparation for the scanner.
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
Title
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.
Description
The number of patients who read the 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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalie GUEGAN
Phone
+33297069684
Email
r.guegan@ghbs.bzh
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosalie GUEGAN
Organizational Affiliation
GHBretagne sud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital du Scorff
City
Lorient
State/Province
Bretagne
ZIP/Postal Code
56100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nolwen Leissen
Phone
+332972067461
Email
n.leissen@ghbs.bzh

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15989996
Citation
de Crevoisier R, Tucker SL, Dong L, Mohan R, Cheung R, Cox JD, Kuban DA. Increased risk of biochemical and local failure in patients with distended rectum on the planning CT for prostate cancer radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):965-73. doi: 10.1016/j.ijrobp.2004.11.032.
Results Reference
background
PubMed Identifier
28620751
Citation
Maggio A, Gabriele D, Garibaldi E, Bresciani S, Delmastro E, Di Dia A, Miranti A, Poli M, Varetto T, Stasi M, Gabriele P. Impact of a rectal and bladder preparation protocol on prostate cancer outcome in patients treated with external beam radiotherapy. Strahlenther Onkol. 2017 Sep;193(9):722-732. doi: 10.1007/s00066-017-1163-4. Epub 2017 Jun 15.
Results Reference
background

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

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