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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Paramedical Consultation, Radiotherapy, Proton Therapy, Brain Tumor

Intervention / Treatment
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* Other: Consultation with Manipulator in Medical Radiology and a radiotherapist
* Other: Consultation with a radiotherapist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist<br> | Other: Consultation with Manipulator in Medical Radiology and a radiotherapist<br>* Weekly consultation with Manipulator in Medical Radiology and a radiotherapist<br>|
| Active Comparator: Standard weekly follow-up by the radiotherapist only<br> | Other: Consultation with a radiotherapist<br>* Weekly consultation with a radiotherapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with at least one toxicity requiring intervention |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of toxicities detected |  | 3 weeks |