Back to resultsInterest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy (MERMOSE)
Primary Purpose
Paramedical Consultation, Radiotherapy, Proton Therapy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Consultation with Manipulator in Medical Radiology and a radiotherapist
Consultation with a radiotherapist
Sponsored by
About this trial
This is an interventional other trial for Paramedical Consultation
Eligibility Criteria
Inclusion Criteria:
- Patient > 18 years;
- Patient with malignant or benign brain or upper aerodigestive tract (ADT) tumor candidate for proton therapy;
- WHO score < 2
- Mastery of the French language;
- Patient affiliated with a social security system;
- Signature of informed consent prior to any specific procedure related to the study.
Exclusion Criteria:
- Patient with another cancer previously treated with radiation therapy;
- Simultaneous participation in a therapeutic clinical trial;
- Patient deprived of liberty or under guardianship;
- Any associated medical or psychological condition that may compromise the patient's ability to participate in the study
- Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons.
Sites / Locations
- Centre François BaclesseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist
Standard weekly follow-up by the radiotherapist only
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with at least one toxicity requiring intervention
Secondary Outcome Measures
Number of toxicities detected
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05404308
Brief Title
Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy
Acronym
MERMOSE
Official Title
Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To our knowledge, the investigators have not found any scientific article dealing with cooperation between radiation oncologists and medical radiation technologists in the context of monitoring patients undergoing radiotherapy. Cooperation protocols between health professionals are in progress but concern mainly technical procedures (ultrasound, laserthermal sessions).
This study aims to evaluate whether MERMs, after training by physicians, can monitor clinical signs (for usual well-described toxicities) during treatment via a dedicated consultation.
This approach participates in the development of new professions and cooperation protocols between health professionals. This mission of accompaniment on a dedicated time would make it possible to develop the caring role of the medical electroradiology manipulator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paramedical Consultation, Radiotherapy, Proton Therapy, Brain Tumor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist
Arm Type
Experimental
Arm Title
Standard weekly follow-up by the radiotherapist only
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Consultation with Manipulator in Medical Radiology and a radiotherapist
Intervention Description
Weekly consultation with Manipulator in Medical Radiology and a radiotherapist
Intervention Type
Other
Intervention Name(s)
Consultation with a radiotherapist
Intervention Description
Weekly consultation with a radiotherapist
Primary Outcome Measure Information:
Title
Proportion of patients with at least one toxicity requiring intervention
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Number of toxicities detected
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient > 18 years;
Patient with malignant or benign brain or upper aerodigestive tract (ADT) tumor candidate for proton therapy;
WHO score < 2
Mastery of the French language;
Patient affiliated with a social security system;
Signature of informed consent prior to any specific procedure related to the study.
Exclusion Criteria:
Patient with another cancer previously treated with radiation therapy;
Simultaneous participation in a therapeutic clinical trial;
Patient deprived of liberty or under guardianship;
Any associated medical or psychological condition that may compromise the patient's ability to participate in the study
Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magali MICAUD, Ms
Phone
+33 2 31 45 51 57
Email
MICAU@baclesse.unicancer.fr
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magali MICAUD, Ms
Phone
+33 2 31 45 51 57
Email
MICAU@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Magali MICAUD, Ms
First Name & Middle Initial & Last Name & Degree
Aurore LECOEUR, Ms
First Name & Middle Initial & Last Name & Degree
Lucie CERMOLACCE, Ms
First Name & Middle Initial & Last Name & Degree
Mark DA SILVA, M
First Name & Middle Initial & Last Name & Degree
Maxime HAMELIN, M
First Name & Middle Initial & Last Name & Degree
François GARGUILO, M
First Name & Middle Initial & Last Name & Degree
Laure LECORDIER, Ms
First Name & Middle Initial & Last Name & Degree
Mathilde VASTEL, Ms
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy
We'll reach out to this number within 24 hrs