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
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedStudy Start
First participant enrolled
May 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedSeptember 17, 2025
September 1, 2025
2.9 years
May 31, 2022
September 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with at least one toxicity requiring intervention
3 weeks
Secondary Outcomes (1)
Number of toxicities detected
3 weeks
Study Arms (2)
Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist
EXPERIMENTALStandard weekly follow-up by the radiotherapist only
ACTIVE COMPARATORInterventions
Weekly consultation with Manipulator in Medical Radiology and a radiotherapist
Weekly consultation with a radiotherapist
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre François Baclesse
Caen, 14076, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 3, 2022
Study Start
May 17, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share