Comparing Immobilisation Shells in Cranial Radiotherapy (CORIOLIS)
A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy
Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent patient movement and improve treatment accuracy. These shells tend to cover the face and have the potential to cause anxiety and distress in patients, particularly if they suffer with claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover the face and compare this with the investigators' current 'closed-face' shell. The investigators will obtain treatment verification x-ray images to assess the daily set-up errors and compare these between the two shell type, and ask both patients and radiographers of their experiences from using the shells.
Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of radiotherapy delivery and are better accepted by patients and radiographers as compared to closed-face immobilisation shells for cranial radiotherapy.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Patients will be randomised into one of two groups, with group A acting as the control group using the investigators' standard 3--point closed--face shell, and group B using the 3--point open--face shell (experimental group). Each procedure is discussed with the patient before commencement. Patients will be positioned into the optimal treatment position and the shell will be fabricated as per manufacturer instructions by pre-treatment radiographers. This is followed by the patient having a planning CT scan of their head while wearing their shell to allows radiographers and doctors to localise and plan the treatment. At the end of this appointment, the patient will be asked to complete the first of three questionnaires regarding their experience of wearing the shell. Radiographers will be asked to complete a questionnaire of their experience of using the shell, and complete timing data for the procedures.
On the first day of treatment, radiographers will discuss the treatment process and side effects of treatment with the patient, and treatment will be delivered under current department protocols using linear accelerators (linacs). During the course of the treatment, radiographers will obtain 5 sets of verification images for the study, and these will be assessed for set-up errors as per current department policy. Where possible, treatment fields will be used to verify patient position to keep radiation doses from verification imaging as low as reasonably practicable (ALARP). Patients will be asked to complete two more questionnaires on their experience, one on their first day and one on their last day of treatment. Radiographers will also complete questionnaires on these days. Timing data will be obtained for all treatment fractions.
The patient's perspective of the planning and treatment processes will be almost identical to that of patients having cranial radiotherapy that are not in the trial. The only differences that will be observed will be the use of an open-face shell (for patients in group B), completion of three questionnaires, and additional verification imaging.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
-
London, Egyesült Királyság, SW3 6JJ
- Royal Marsden Hospital NHS Foundation Trust
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- patients prescribed cranial radiotherapy using virtually simulated parallel opposed fields with:
- 5 or more fractions of virtually simulated cranial radiotherapy
- treatment for Primary Central Nervous System Lymphoma (PCNSL), prophylactic cranial irradiation (PCI), or primary or secondary cerebral or bony lesions
Exclusion Criteria:
- patients unable to give informed consent
- patients requiring conformal or inverse-planned radiotherapy
- patients requiring stereotactic radiotherapy
- patients who have previously had cranial or head and neck radiotherapy
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: Group A: Closed-face shells
Cranial radiotherapy using the control closed-face immobilisation shell.
|
As for arm description
|
|
Kísérleti: Group B: open-face shell
Cranial radiotherapy using the experimental open-face immobilisation shell
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As for arm description
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
Időkeret: within 2 weeks of completion of treatment
|
Assessment of verification imaging to determine individual systematic and random errors.
Individual errors are collated to determine group systematic and random errors for comparison.
|
within 2 weeks of completion of treatment
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Timing data
Időkeret: within 2 weeks of patient completion of treatment
|
Completion of data on time taken for setup, imaging, and total appointment time
|
within 2 weeks of patient completion of treatment
|
|
Assessment of imaging to determine intra-fraction motion
Időkeret: within 2 weeks of patient completion of treatment
|
Comparison of verification imaging with in-treatment imaging records to determine magnitude of intra-fraction motion.
These will be assessed per patient and compared between both groups.
|
within 2 weeks of patient completion of treatment
|
|
Patient acceptance and tolerability of immobilisation shells (pre-treatment)
Időkeret: within 2 weeks of patient completion of treatment
|
Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during fabrication (moulding) and planning CT scan.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
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within 2 weeks of patient completion of treatment
|
|
Patient acceptance and tolerability of immobilisation shells (1st fraction)
Időkeret: within 2 weeks of patient completion of treatment
|
Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during first radiotherapy treatment session.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
|
within 2 weeks of patient completion of treatment
|
|
Patient acceptance and tolerability of immobilisation shells (last fraction)
Időkeret: within 2 weeks of patient completion of treatment
|
Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during last radiotherapy treatment session.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
|
within 2 weeks of patient completion of treatment
|
|
Radiographer satisfaction of using immobilisation shells (pre-treatment)
Időkeret: within 2 weeks of patient completion of treatment
|
Radiographer completion of questionnaire to determine satisfaction with fabrication and use of immobilisation shell during pre-treatment stages.
Pre-treatment and treatment questionnaires will be analysed individually and together to determine any differences between both groups.
|
within 2 weeks of patient completion of treatment
|
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Radiographer satisfaction of using immobilisation shells (treatment)
Időkeret: within 2 weeks of patient completion of treatment
|
Radiographer completion of questionnaire to determine satisfaction with use of immobilisation shell during treatment.
The same questionnaire is used at the first and last fraction of treatment.
Pre-treatment and treatment questionnaires will be analysed individually and together to determine any differences between both groups.
|
within 2 weeks of patient completion of treatment
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Liam Welsh, PhD, FRCR, Royal Marsden NHS Foundation Trust
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CCR4362
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- ICF
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