Clinical trial NCT05149521: Recommendations for a Radiotherapy Comfort Intervention Package Radiotherapy
Official title: A Consensus Study Using Nominal Group Technique to Develop Recommendations for a Comfort Intervention Package in Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology
Lead sponsor: University of the West of England
Sponsor class: OTHER
Collaborators: name: Somerset NHS Foundation Trust
First posted: 2021-12-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aiming to recruit between three main anatomical regions: head and neck, thorax and pelvis.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prioritisation of comfort interventions applicable to radiotherapy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Somerset NHS Foundation Trust
name: Simon Goldsworthy, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.