NCT03984435

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

June 10, 2019

Last Update Submit

June 11, 2019

Conditions

Cancer

Keywords

RadiotherapyExperiencesComfort managementPatientsRadiographers

Outcome Measures

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.

    Duration of radiotherapy and up to three months after

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients:
  • diagnosed with a malignancy;
  • aged over 18 years owing to different treatment options for children and young adults;
  • recently referred for radiotherapy, currently receiving treatment or had had radiotherapy within the previous 3 months;
  • treatment delivery time exceeding 10 minutes (the time the patient is immobilised on the radiotherapy couch).
  • Therapeutic radiographers:
  • practicing Therapeutic radiographers;
  • administering radiotherapy with treatment delivery times exceeding 10 minutes per radiotherapy treatment session (the time the patient is immobilised on the radiotherapy couch).

You may not qualify if:

  • Patients:
  • patients with treatment delivery time below 10 minutes;
  • unable to communicate in English.
  • Therapeutic Radiographers:
  • student Therapeutic radiographers,
  • no more than two radiographers from the same radiotherapy department.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Musgrove Park Hospital

Taunton, Somerset, TA15DA, United Kingdom

RECRUITING

Related Publications (14)

  • 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.

    PMID: 19380502BACKGROUND

  • 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.

    PMID: 22257653BACKGROUND

  • 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.

    PMID: 28409420BACKGROUND

  • 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.

    PMID: 28237218BACKGROUND

  • 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.

    PMID: 14752735BACKGROUND

  • 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

    BACKGROUND

  • Cox.J. Davison.A. Comfort as a determiner of treatment position in radiotherapy of the male pelvis. Radiog. 2005; 11 (2): 109-115

    BACKGROUND

  • 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

    BACKGROUND

  • Pineau,C. The psychological meaning of comfort. International Review of Applied Psychology. 1982. Vol 31, 271-283

    BACKGROUND

  • 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.

    PMID: 11847691BACKGROUND

  • 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.

    PMID: 17099440BACKGROUND

  • Braun V. Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology; 2006 July 3: 77-101

    BACKGROUND

  • 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.

    PMID: 25158659BACKGROUND

  • Goldsworthy S, Latour JM, Palmer S, McNair HA, Cramp M. A thematic exploration of patient and radiation therapist solutions to improve comfort during radiotherapy: A qualitative study. J Med Imaging Radiat Sci. 2023 Dec;54(4):603-610. doi: 10.1016/j.jmir.2023.07.008. Epub 2023 Jul 20.

    PMID: 37479627DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Simon D Goldsworthy, MSc

    Principal Research Radiographer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon D Goldsworthy, MSc

CONTACT

01823 344250Simon.goldsworthy@tst.nhs.uk

Susan J Mahoney, BSc

CONTACT

01823 343369Susan.mahoney@tst.nhs.uk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 13, 2019

Study Start

February 8, 2019

Primary Completion

August 15, 2019

Study Completion

December 31, 2019

Last Updated

June 13, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Access to anonymised interview transcripts on written request to UWE Bristol

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
10 years from production of data
Access Criteria
Via DMPonline
More information

Locations

GB(1)