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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03984435
Other study ID # HAS.19.02.126
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 8, 2019
Est. completion date December 31, 2019

Study information

Verified date June 2019
Source University of the West of England
Contact Simon D Goldsworthy, MSc
Phone 01823 344250
Email Simon.goldsworthy@tst.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2019
Est. primary completion date August 15, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Musgrove Park Hospital Taunton Somerset

Sponsors (2)

Lead Sponsor Collaborator
University of the West of England Taunton and Somerset NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (13)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

Dawson LA, Balter JM. Interventions to reduce organ motion effects in radiation delivery. Semin Radiat Oncol. 2004 Jan;14(1):76-80. — View Citation

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. — View Citation

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

Kolcaba K, Steiner R. Empirical evidence for the nature of holistic comfort. J Holist Nurs. 2000 Mar;18(1):46-62. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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