Recommendations for a Radiotherapy Comfort Intervention Package Radiotherapy
NCT ID: NCT05149521
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
12 participants
OBSERVATIONAL
2021-12-01
2022-08-31
Brief Summary
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Detailed Description
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The aim of this study is to develop a radiotherapy comfort intervention package with patients and therapeutic radiographers.
The objectives are to:
Objective 1 - Identify and prioritise intervention components for inclusion in recommendations for a radiotherapy comfort intervention package.
Objective 2 - Determine the feasibility of delivering the component of the radiotherapy comfort intervention package.
Modified nominal group technique (NGT) will employed to develop recommendations for a comfort intervention package in radiotherapy in a consensus study with patients and therapeutic radiographers. This study follows earlier phases of the COMFORT study which included a systematic literature review of comfort interventions applicable to radiotherapy and qualitative interviews exploring comfort management in radiotherapy.
Study Participants
Patients
The inclusion criteria are: 1) diagnosed with a malignancy; 2) aged over 18 years owing to different treatment options for children and young adults; 3) recently referred for radiotherapy, currently receiving treatment or had had radiotherapy within the previous 3 months; 4) treatment delivery time exceeding 10 minutes (the time the patient is immobilised on the radiotherapy couch).
Therapeutic radiographers
The inclusion criteria are: 1) practicing radiographers; 2) administering radiotherapy with treatment delivery times exceeding 10 minutes per radiotherapy treatment session (the time the patient is immobilised on the radiotherapy couch).
The consensus study will be conducted by video conference.
Planned Size of Sample (if applicable)
6-12 participants (4-9 Patients and 2-3 Therapeutic radiographers)
Follow up duration (if applicable)
Follow up is not planned.
Planned Study Period
6 months
Research Question/Aim(s)
The aim of this study is to develop recommendations for a radiotherapy comfort intervention with patients and therapeutic radiographers.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients who have received radiotherapy
This is a consensus study with no interventions Patients who previously participated in COMFORT study interviews (NCT03984435)
None - this is a consensus group study to develop an intervention
None - this is a consensus group study to develop an intervention
Therapeutic radiographers who deliver radiotherapy
This is a consensus study with no interventions Therapeutic radiographers who previously participated in COMFORT study interviews (NCT03984435)
None - this is a consensus group study to develop an intervention
None - this is a consensus group study to develop an intervention
Interventions
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None - this is a consensus group study to develop an intervention
None - this is a consensus group study to develop an intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Somerset NHS Foundation Trust
OTHER
University of the West of England
OTHER
Responsible Party
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Principal Investigators
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Simon Goldsworthy, MSc
Role: PRINCIPAL_INVESTIGATOR
Somerset NHS Foundation Trust
Central Contacts
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References
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Goldsworthy S, Palmer S, Latour JM, McNair H, Cramp M. A systematic review of effectiveness of interventions applicable to radiotherapy that are administered to improve patient comfort, increase patient compliance, and reduce patient distress or anxiety. Radiography (Lond). 2020 Nov;26(4):314-324. doi: 10.1016/j.radi.2020.03.002. Epub 2020 Mar 31.
Other Identifiers
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HAS..21.10.024
Identifier Type: -
Identifier Source: org_study_id