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Status unknownNCT03984435COMFORTUpdated Jun 13, 2019

Patients' and Radiographers' Experiences and Views of Comfort Management in Radiotherapy

An observational study in Cancer, sponsored by University of the West of England. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by University of the West of England · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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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Conditions studied

  • Cancer

Keywords

  • Radiotherapy
  • Experiences
  • Comfort management
  • Patients
  • Radiographers
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In context

Lead sponsor

University of the West of England is the lead sponsor of 26 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Experiences of comfort during radiotherapy - qualitative (non-standard outcome measure)

    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.

    Time frame: Duration of radiotherapy and up to three months after

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Schnur JB, Ouellette SC, Bovbjerg DH, Montgomery GH. Breast cancer patients' experience of external-beam radiotherapy. Qual Health Res. 2009 May;19(5):668-76. doi: 10.1177/1049732309334097. PubMed 19380502 ↗
  • Arcangeli S, Scorsetti M, Alongi F. Will SBRT replace conventional radiotherapy in patients with low-intermediate risk prostate cancer? A review. Crit Rev Oncol Hematol. 2012 Oct;84(1):101-8. doi: 10.1016/j.critrevonc.2011.11.009. Epub 2012 Jan 17. PubMed 22257653 ↗
  • Gestaut MM, Thawani N, Kim S, Gutti VR, Jhavar S, Deb N, Morrow A, Ward RA, Huang JH, Patel M. Single fraction spine stereotactic ablative body radiotherapy with volumetric modulated arc therapy. J Neurooncol. 2017 May;133(1):165-172. doi: 10.1007/s11060-017-2428-6. Epub 2017 Apr 13. PubMed 28409420 ↗
  • Chang JH, Gandhidasan S, Finnigan R, Whalley D, Nair R, Herschtal A, Eade T, Kneebone A, Ruben J, Foote M, Siva S. Stereotactic Ablative Body Radiotherapy for the Treatment of Spinal Oligometastases. Clin Oncol (R Coll Radiol). 2017 Jul;29(7):e119-e125. doi: 10.1016/j.clon.2017.02.004. Epub 2017 Feb 23. PubMed 28237218 ↗
  • Dawson LA, Balter JM. Interventions to reduce organ motion effects in radiation delivery. Semin Radiat Oncol. 2004 Jan;14(1):76-80. doi: 10.1053/j.semradonc.2003.10.010. PubMed 14752735 ↗
  • 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
  • Kolcaba K, Steiner R. Empirical evidence for the nature of holistic comfort. J Holist Nurs. 2000 Mar;18(1):46-62. doi: 10.1177/089801010001800106. PubMed 11847691 ↗
  • Kolcaba K, Tilton C, Drouin C. Comfort Theory: a unifying framework to enhance the practice environment. J Nurs Adm. 2006 Nov;36(11):538-44. doi: 10.1097/00005110-200611000-00010. PubMed 17099440 ↗
  • Braun V. Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology; 2006 July 3: 77-101
  • Carter N, Bryant-Lukosius D, DiCenso A, Blythe J, Neville AJ. The use of triangulation in qualitative research. Oncol Nurs Forum. 2014 Sep;41(5):545-7. doi: 10.1188/14.ONF.545-547. PubMed 25158659 ↗

Individual participant data

Plan to share: Yes — Access to anonymised interview transcripts on written request to UWE Bristol

Supporting information: Study protocol, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03984435
Lead sponsor
University of the West of England
Collaborators
Somerset NHS Foundation Trust
Responsible party
Sponsor
First posted
Jun 13, 2019
Start date
Feb 8, 2019
Primary completion
Aug 15, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Jun 13, 2019

Study contacts

Simon D Goldsworthy, MSc
Contact
Simon.goldsworthy@tst.nhs.uk
01823 344250
Susan J Mahoney, BSc
Contact
Susan.mahoney@tst.nhs.uk
01823 343369
Simon D Goldsworthy, MSc
principal investigator · Principal Research Radiographer

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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