Clinical trial NCT05910229: Telephone Paramedical Support Prior to the Radiotherapy Simulation Scanner for Patients with Prostate Cancer
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
Overall status: COMPLETED
Phase: NA
Conditions: Radiotherapy
Prostate Cancer
Keywords: paramedical phone call
Lead sponsor: Groupe Hospitalier de Bretagne Sud
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative monocentric study with randomisation between two parallel arms
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: Assess the impact of a telephone call upstream of the simulation scanner on patient preparation according to recommendations.
timeFrame: From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
measure: 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.
timeFrame: From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
Other outcomes:
Locations:
city: Lorient
country: France
facility: Hôpital du Scorff
state: Bretagne
Study officials:
affiliation: GHBretagne sud
name: Rosalie GUEGAN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.