Recommendations for a Radiotherapy Comfort Intervention Package Radiotherapy

Oncology Clinical Trial

Official title:

A Consensus Study Using Nominal Group Technique to Develop Recommendations for a Comfort Intervention Package in Radiotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05149521
• Other study ID #: HAS..21.10.024
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2021
• Source: University of the West of England
• Contact: Simon Goldsworthy, MSc
• Phone: 01823344250
• Email: simon.goldsworthy[@]somersetft.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: August 31, 2022
• Est. primary completion date: March 15, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients and therapeutic radiographers who previously participated in COMFORT study interviews

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of the West of England	Somerset NHS Foundation Trust

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   OC-0313 Future solutions to improve comfort during radiotherapy: patient & radiation therapist interviews