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

Prostate Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910229
• Other study ID #: 56LORC_2021_RTEPROST
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: March 9, 2025

Study information

• Verified date: February 2024
• Source: Groupe Hospitalier de Bretagne Sud
• Contact: Rosalie GUEGAN
• Phone: +33297069684
• Email: r.guegan[@]ghbs.bzh
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 9, 2025
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy

Intervention

Other:
• Phone call
In the experimental arm the patient will be called 3 days before the CT scan

Locations

Country	Name	City	State
France	Hôpital du Scorff	Lorient	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de Bretagne Sud

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
Secondary	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.	From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
Secondary	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	From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion