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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:
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without Non-magnetic screen | No Intervention | Radiotherapy treatment with Linac MRI without non-magnetic shielding | |
| With non-magnetic screen | Experimental | Radiotherapy treatment with Linac MRI with non-magnetic screen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With non-magnetic screen | Combination Product | Radiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will guide the patient to block the breathing |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine). | 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. | During 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient respiratory effort with visual analog scale | 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 | During 25 months |
| The positional pain with visual analog scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilles TRUC, Doctor | Contact | 03 80 73 75 18 | +33 | gtruc@cgfl.fr |
| Sophie PARNALLAND, Project Manager | Contact | 03 45 34 80 77 | +33 | sparnalland@cgfl.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges-François Leclerc | Recruiting | Dijon | Côte d'Or | 21000 | France |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D008113 | Liver Neoplasms |
| D007680 | Kidney Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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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 |
| During 25 months |
| Level of anxiety/stress evaluated with the Spielberg scale via the STAI-Y-form grid | 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. | During 25 months |
| The potential time | Evaluate whether the potential time savings in screen time compensates for the time spent learning the screen during the simulation. | During 25 months |
| The patient satisfaction evaluated with an ad-hoc questionnaire. | 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. | During 25 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000307 | Adrenal Gland Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |