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 (MERMOSE)

Centre Francois Baclesse

Status: Enrolling

Conditions: Brain Tumor; Proton Therapy; Radiotherapy; Paramedical Consultation

Treatments: Other: Consultation with Manipulator in Medical Radiology and a radiotherapist; Other: Consultation with a radiotherapist

Study type: Interventional

Funder types: Other

Identifiers

NCT05404308

2021-A00499-32

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

92 participants in 2 patient groups

Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist

Experimental group

Treatment:

Other: Consultation with Manipulator in Medical Radiology and a radiotherapist

Standard weekly follow-up by the radiotherapist only

Active Comparator group

Treatment:

Other: Consultation with a radiotherapist