Recommendations for a Radiotherapy Comfort Intervention Package Radiotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oncology
• Intervention / Treatment: Other: None - this is a consensus group study to develop an intervention

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 Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

• Study Contact: Name: Simon Goldsworthy, MSc; Phone Number: 01823344250; Email: simon.goldsworthy@somersetft.nhs.uk
• Study Contact Backup: Name: Tamlyn Russel, BSc; Phone Number: 01823343369; Email: tamlyn.russel@somersetft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; None - this is a consensus group study to develop an intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of the West of England
• Collaborators: Somerset NHS Foundation Trust
• Investigators: Principal Investigator: Simon Goldsworthy, MSc, Somerset NHS Foundation Trust

Publications and helpful links

General 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): March 15, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HAS..21.10.024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: After the study completion for 10 years

IPD Sharing 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:

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No