OncologyNCT05149521
Recommendations for a Radiotherapy Comfort Intervention Package Radiotherapy
An observational study of Oncology, run by University of the West of England.
Trial summary
A consensus study using nominal group technique is planned to develop recommendations for a comfort intervention package for radiotherapy with patients and therapeutic radiographers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- None - this is a consensus group study to develop an intervention
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Aiming to recruit between three main anatomical regions: head and neck, thorax and pelvis.
Who may be able to join
- Patients and therapeutic radiographers who previously participated in COMFORT study interviews
Who cannot join
- Patients and therapeutic radiographers who did not participate in COMFORT study interviews
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Consensus Study Using Nominal Group Technique to Develop Recommendations for a Comfort Intervention Package in Radiotherapy
A consensus study using nominal group technique is planned to develop recommendations for a comfort intervention package for radiotherapy with patients and therapeutic radiographers. This includes completed work from a systematic literature review (Prospero 59688) of comfort interventions applicable to radiotherapy and qualitative interviews (NCT03984435) with patients and therapeutic radiographers exploring comfort management in radiotherapy.
Read the detailed description
Study Design
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
- Oncology
- Being tested
- None - this is a consensus group study to develop an intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - this is a consensus group study to develop an interventionOther
None - this is a consensus group study to develop an intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients who have received radiotherapy | This is a consensus study with no interventions Patients who previously participated in COMFORT study interviews (NCT03984435) Receives: Other: 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) Receives: Other: None - this is a consensus group study to develop an intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prioritisation of comfort interventions applicable to radiotherapy
Consensus among patients and therapeutic radiographers using nominal group technique to achieve priority of comfort interventions
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Collaborators
- Somerset NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Simon Goldsworthy, MSc, Principal investigator, Somerset NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149521
- Sponsor's protocol ID
- HAS..21.10.024
- Status last verified
- Nov 2021
- First submitted
- 23 Sep 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be the property of the Chief Investigator at the University of the West of England who is the data controller. Other researchers can request access to study data via the University of the West of England
Publications
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.
PubMed 32245711
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Consensus Study Using Nominal Group Technique to Develop Recommendations for a Comfort Intervention Package in Radiotherapy
- ClinicalTrials.gov ID
- NCT05149521
- Acronym / sponsor ID
- HAS..21.10.024
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Collaborators
- Somerset NHS Foundation Trust
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A consensus study using nominal group technique is planned to develop recommendations for a comfort intervention package for radiotherapy with patients and therapeutic radiographers. This includes completed work from a systematic literature review (Prospero 59688) of comfort interventions applicable to radiotherapy and qualitative interviews (NCT03984435) with patients and therapeutic radiographers exploring comfort management in radiotherapy.
Detailed description
Study Design
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who have received radiotherapy | – | Other: None - this is a consensus group study to develop an interventionThis is a consensus study with no interventions Patients who previously participated in COMFORT study interviews (NCT03984435) |
| Therapeutic radiographers who deliver radiotherapy | – | Other: None - this is a consensus group study to develop an interventionThis is a consensus study with no interventions Therapeutic radiographers who previously participated in COMFORT study interviews (NCT03984435) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Aiming to recruit between three main anatomical regions: head and neck, thorax and pelvis.
Key inclusion criteria (1 listed)
- Patients and therapeutic radiographers who previously participated in COMFORT study interviews
Key exclusion criteria (1 listed)
- Patients and therapeutic radiographers who did not participate in COMFORT study interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - this is a consensus group study to develop an interventionNone - this is a consensus group study to develop an intervention | Other | Patients who have received radiotherapy, Therapeutic radiographers who deliver radiotherapy |
Primary outcome
Prioritisation of comfort interventions applicable to radiotherapy
Time frame: 1 month
Consensus among patients and therapeutic radiographers using nominal group technique to achieve priority of comfort interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Background: PubMed 32245711Goldsworthy 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.
- Individual participant dataSharing planned: Yes. The data will be the property of the Chief Investigator at the University of the West of England who is the data controller. Other researchers can request access to study data via the University of the West of England
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Goldsworthy, MSc principal investigator
Somerset NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by University of the West of England.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Goldsworthy, MSc (01823344250, simon.goldsworthy@somersetft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prioritisation of comfort interventions applicable to radiotherapy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.