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

NCT ID: NCT05910229

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2025-01-09

Brief Summary

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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

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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.

Conditions

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Radiotherapy Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

comparative monocentric study with randomisation between two parallel arms
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Patient with standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Phone call

Intervention Type OTHER

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

Interventions

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Phone call

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier de Bretagne Sud

OTHER

Sponsor Role lead

Responsible Party

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Rosalie Guegan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosalie GUEGAN

Role: PRINCIPAL_INVESTIGATOR

GHBretagne sud

Locations

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Hôpital du Scorff

Lorient, Brittany Region, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 15989996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28620751 (View on PubMed)

Other Identifiers

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56LORC_2021_RTEPROST

Identifier Type: -

Identifier Source: org_study_id

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