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

NCT05910229 | Completed

• 1 other identifier: 56LORC_2021_RTEPROST
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy; Prostate Cancer

Keywords

paramedical phone call

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (2)

• 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

• 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

Study Arms (2)

Patient with standard care

NO INTERVENTION

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

Patient with personalized support

EXPERIMENTAL

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

Interventions

Phone call OTHER

In the experimental arm the patient will be called 3 days before the CT scan

Patient with personalized support

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier de Bretagne Sud: lead

Study Sites (1)

Hôpital du Scorff

Lorient, Brittany Region, 56100, France

Location

Related 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.

  PMID: 15989996 BACKGROUND

• 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.

  PMID: 28620751 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Rosalie GUEGAN

  GHBretagne sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: comparative monocentric study with randomisation between two parallel arms

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 18, 2023
• Study Start: November 9, 2022
• Primary Completion: November 9, 2024
• Study Completion: January 9, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)