RadiotherapyRTEPROSTNCT05910229
Telephone Paramedical Support Prior to the Radiotherapy Simulation Scanner for Patients with Prostate Cancer
A study testing Phone call in people with Radiotherapy and Prostate Cancer, run by Groupe Hospitalier de Bretagne Sud at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Radiotherapy, Prostate Cancer
- What is being tested?
- Phone call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2022to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient not understanding French
- Patient not reachable by phone
- Individual of full age deprived of liberty or placed under a legal protection measure
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Radiotherapy, Prostate Cancer
- Being tested
- Phone call
- Keywords
- paramedical phone call
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callOther
In the experimental arm the patient will be called 3 days before the CT scan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The number of patients who performed the preparation for the scanner.
Measured: 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.
The number of patients who read the recommendations
Measured: From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start9 Nov 2022
- Primary completion9 Nov 2024
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative monocentric study with randomisation between two parallel arms
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de Bretagne Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosalie Guegan, Groupe Hospitalier de Bretagne Sud
- Investigators
- Rosalie GUEGAN, Principal investigator, GHBretagne sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910229
- Sponsor's protocol ID
- 56LORC_2021_RTEPROST
- Acronym
- RTEPROST
- Status last verified
- Mar 2025
- First submitted
- 5 May 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15989996Maggio 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.
PubMed 28620751
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05910229
- Acronym / sponsor ID
- RTEPROST / 56LORC_2021_RTEPROST
- Conditions
- Radiotherapy, Prostate Cancer
- Keywords
- paramedical phone call
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Groupe Hospitalier de Bretagne SudUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- comparative monocentric study with randomisation between two parallel arms
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Phone callConsultation 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patient not understanding French
- Patient not reachable by phone
- Individual of full age deprived of liberty or placed under a legal protection measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callIn the experimental arm the patient will be called 3 days before the CT scan | Other | Patient with personalized support |
Primary outcome
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.
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
The proportion of patients for whom it is necessary to renew the CT scanner simulation.
2 secondary outcomes
Assess the impact of a telephone call upstream of the simulation scanner on patient preparation according to 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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 15989996de 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.
- Background: PubMed 28620751Maggio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalie GUEGAN principal investigator
GHBretagne sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call in people with Radiotherapy and Prostate Cancer, run by Groupe Hospitalier de Bretagne Sud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910229, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.