Mobile Cancerous Lesion, Patient With Radiotherapy (Linac MRI)
Conditions
Keywords
Linac IRM, Pancreatic cancer, Liver cancer, Kidney cancer, Adrenal cancer, Lung cancer, Adenopathy above or below the diaphragm
Brief summary
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...). After signing the consent form, each patient will be randomized to one of two treatment arms: * Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding * Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen The aim is to evaluate the effect of using a non-magnetic screen visible to the patient in the bunker during radiotherapy sessions delivered by Linac MRI on decreasing the ratio between the actual treatment time and the treatment time predicted by the machine.
Detailed description
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...). After signing the consent form, each patient will be randomized to one of two treatment arms: * Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding * Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen The aim is to compare the effect of the non-magnetic screen on the blocking of the patient's breathing versus the current procedure (the blocking of the breathing is informed by the staff) The patients will each receive 5 sessions of radiotherapy on Linac MRI. 100 patients are expected to participate in this study Before each session will be assessed for anxiety and stress. After each session will be evaluated patient satisfaction, pain intensity and respiratory effort. The duration of the treatment and therefore of the follow-up of the patient in the study is 1 to 2 weeks
Interventions
COMBINATION_PRODUCTWith non-magnetic screen
Radiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will guide the patient to block the breathing
Sponsors
Centre Georges Francois Leclerc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 18 years old * Patient starting radiotherapy on Linac MRI for a mobile cancerous lesion most often in the pancreas, liver, kidneys, adrenals, lung, supra or subdiaphragmatic adenopathy * Patient affiliated to the social security system
Exclusion criteria
* Patient with lesions not detected by the device's tracking system * Patient with visual disturbances * Contraindications to treatment with Linac MRI (epileptic patients, pregnant or breastfeeding women, metallic prosthesis or pacemaker not compatible with MRI) * Patients with cognitive disorders * Persons deprived of liberty or under guardianship (including curatorship) * Pregnant or nursing woman * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine). | During 25 months | To evaluate the effect of a non-magnetic screen visible to the patient in the bunker during radiation therapy sessions delivered by Linac MRI on decreasing the ratio of actual treatment time to the treatment time predicted by the machine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient respiratory effort with visual analog scale | During 25 months | Patient respiratory effort for each radiotherapy session according to randomization arm. The scale is graduated from 0 to 10 with 10 = maximum respiratory discomfort and 0 = no respiratory discomfort |
| The positional pain with visual analog scale | During 25 months | Compare the positional pain associated with setting up on the treatment table for each radiation therapy session according to the randomization arm. The scale is graduated from 0 to 10 with 0 = absence of pain and 10 = maximum pain |
| Level of anxiety/stress evaluated with the Spielberg scale via the STAI-Y-form grid | During 25 months | To assess the average level of anxiety/stress for each radiation therapy session according to the randomization arm. The Spielberg scale via the STAI-form Y-A grid is used before each treatment session in order to follow the evolution of the patients' emotional state. 20 questions with 4 possible answers : 1/ Not at all, 2/ A little, 3/Moderately , 4/ A lot. |
| The potential time | During 25 months | Evaluate whether the potential time savings in screen time compensates for the time spent learning the screen during the simulation. |
| The patient satisfaction evaluated with an ad-hoc questionnaire. | During 25 months | The patient's satisfaction with his or her involvement in the treatment process will be evaluated at the end of the 5 radiotherapy sessions using an ad-hoc questionnaire. |
Countries
France
Contacts
Primary ContactGilles TRUC, Doctor
Backup ContactSophie PARNALLAND, Project Manager
Outcome results
None listed