Recommendations for a Radiotherapy Comfort Intervention Package Radiotherapy

NCT05149521 | Unknown

• 1 other identifier: HAS..21.10.024
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

• Prioritisation of comfort interventions applicable to radiotherapy

  Consensus among patients and therapeutic radiographers using nominal group technique to achieve priority of comfort interventions

  1 month

Study Arms (2)

Patients who have received radiotherapy

This is a consensus study with no interventions Patients who previously participated in COMFORT study interviews (NCT03984435)

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)

Other: None - this is a consensus group study to develop an intervention

Interventions

None - this is a consensus group study to develop an intervention OTHER

None - this is a consensus group study to develop an intervention

Patients who have received radiotherapy; Therapeutic radiographers who deliver radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aiming to recruit between three main anatomical regions: head and neck, thorax and pelvis.

You may qualify if:

• Patients and therapeutic radiographers who previously participated in COMFORT study interviews

You may not qualify if:

• Patients and therapeutic radiographers who did not participate in COMFORT study interviews

Sponsors & Collaborators

• University of the West of England: lead
• Somerset NHS Foundation Trust: collaborator

Related Publications (1)

• 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.

  PMID: 32245711 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Simon Goldsworthy, MSc

  Somerset NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Goldsworthy, MSc

CONTACT

01823344250; simon.goldsworthy@somersetft.nhs.uk

Tamlyn Russel, BSc

CONTACT

01823343369; tamlyn.russel@somersetft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: December 8, 2021
• Study Start: December 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: August 31, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study completion for 10 years
• Access Criteria: The data will be the property of the Chief Investigator at the University of the West of England who is the data controller. A full data management plan can be found in the UWE research repository at the following URL: