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

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ClinicalTrials.gov Identifier: NCT03984435
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Taunton and Somerset NHS Foundation Trust
Information provided by (Responsible Party):
University of the West of England

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

Condition or disease
Cancer

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Qualitative Study Exploring Patient Experiences of Comfort During Radiotherapy and Radiographer Views of Managing Patient Comfort During the Delivery of Radiotherapy
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : December 31, 2019

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984435


Contacts
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Contact: Simon D Goldsworthy, MSc 01823 344250 Simon.goldsworthy@tst.nhs.uk
Contact: Susan J Mahoney, BSc 01823 343369 Susan.mahoney@tst.nhs.uk

Locations
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United Kingdom
Musgrove Park Hospital Recruiting
Taunton, Somerset, United Kingdom, TA15DA
Contact: Simon D Goldsworthy, MSc    01823 344250    Simon.goldsworthy@tst.nhs.uk   
Contact: Susan J Mahoney    01823 343369    Susan.mahoney@tst.nhs.uk   
Sponsors and Collaborators
University of the West of England
Taunton and Somerset NHS Foundation Trust
Investigators
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Principal Investigator: Simon D Goldsworthy, MSc Principal Research Radiographer

Additional Information:
Publications:
Cheng. F, Wang.W. Factors influencing comfort level in head and neck neoplasm patients receiving radiotherapy. Int J Nur Scie. 2014; 1 (4): 394-399
Cox.J. Davison.A. Comfort as a determiner of treatment position in radiotherapy of the male pelvis. Radiog. 2005; 11 (2): 109-115
Goldsworthy.SD, Tuke.K, Latour.J.M. A focus group consultation round exploring patient experiences of comfort during radiotherapy for head and neck cancer; Journal of Radiotherapy in Practice; 2016; 15 (2)143-149
Pineau,C. The psychological meaning of comfort. International Review of Applied Psychology. 1982. Vol 31, 271-283
Braun V. Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology; 2006 July 3: 77-101

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Responsible Party: University of the West of England
ClinicalTrials.gov Identifier: NCT03984435     History of Changes
Other Study ID Numbers: HAS.19.02.126
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymised interview transcripts on written request to UWE Bristol
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 10 years from production of data
Access Criteria: Via DMPonline
URL: http://dmponline.dcc.sc.uk

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of the West of England:
Radiotherapy
Experiences
Comfort management
Patients
Radiographers