Patients' and Radiographers' Experiences and Views of Comfort Management in Radiotherapy (COMFORT)

June 11, 2019 updated by: University of the West of England

A Qualitative Study Exploring Patient Experiences of Comfort During Radiotherapy and Radiographer Views of Managing Patient Comfort During the Delivery of Radiotherapy

A qualitative study exploring patient experiences of comfort during radiotherapy and radiographers' views of managing patient comfort during the delivery of radiotherapy

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients undergoing radiotherapy treatment for cancer frequently express their feelings of discomfort during the procedure, especially those who require radiotherapy with extended treatment times. This problem was explored by informal questioning of patients who revealed that this is a problem and causes distress and discomfort but that it was being accepted as being part of the treatment. In healthcare, several interventions have been used to improve the comfort of patients. In radiotherapy, there have been examples where positioning or relaxation has improved the patient's comfort. Literature searches have revealed some comfort interventions that can be used during radiotherapy treatment which may be possible interventions.

With the consent of the patient, it is intended to establish the patients' experience and views of comfort and comfort management during radiotherapy. Radiographers' experiences and views of managing patient comfort during radiotherapy will also be explored. It will also be essential to explore what would be the most ideal solution to comfort management, or how comfort could be improved, from the perspective of both patients and radiographers.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patients: any person receiving radiotherapy at Musgrove Park Hospital, Taunton, with Therapeutic radiographers: no more than two from any radiotherapy department throughout the UK.

Description

Inclusion Criteria:

Patients:

  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:

  1. practicing Therapeutic 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).

Exclusion Criteria:

Patients:

  1. patients with treatment delivery time below 10 minutes;
  2. unable to communicate in English.

Therapeutic Radiographers:

  1. student Therapeutic radiographers,
  2. no more than two radiographers from the same radiotherapy department.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
Patients with a diagnosed malignancy who have been referred for radiotherapy with extended treatment time (>10 minutes)
Radiographers
Radiographers from radiotherapy departments in the UK who deliver radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experiences of comfort during radiotherapy - qualitative (non-standard outcome measure)
Time Frame: Duration of radiotherapy and up to three months after
This is qualitative research and the outcomes are derived from transcribed interviews analysed thematically generating codes, themes and sub-themes of patient and radiographers lived experiences of comfort during radiotherapy.
Duration of radiotherapy and up to three months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the West of England

Collaborators

Somerset NHS Foundation Trust

Investigators

  • Principal Investigator: Simon D Goldsworthy, MSc, Principal Research Radiographer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2019

Primary Completion (Anticipated)

August 15, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 11, 2019

First Posted (Actual)

June 13, 2019

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HAS.19.02.126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymised interview transcripts on written request to UWE Bristol

IPD Sharing Time Frame

10 years from production of data

IPD Sharing Access Criteria

Via DMPonline

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe