CancerCOMFORTNCT03984435
Patients' and Radiographers' Experiences and Views of Comfort Management in Radiotherapy
An observational study of Cancer, run by University of the West of England at 1 site in United Kingdom.
Trial summary
A qualitative study exploring patient experiences of comfort during radiotherapy and radiographers' views of managing patient comfort during the delivery of radiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Feb 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Musgrove Park Hospital
Taunton, Somerset, TA15DA
Simon D Goldsworthy, MSc, 01823 344250, Simon.goldsworthy@tst.nhs.uk
Susan J Mahoney, 01823 343369, Susan.mahoney@tst.nhs.uk
About this study
Official title: 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
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.
- Conditions
- Cancer
- Keywords
- Radiotherapy, Experiences, Comfort management, Patients, Radiographers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of radiotherapy and up to three months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start8 Feb 2019
- Primary completion15 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Collaborators
- Somerset NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Simon D Goldsworthy, MSc, Principal investigator, Principal Research Radiographer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984435
- Sponsor's protocol ID
- HAS.19.02.126
- Acronym
- COMFORT
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymised interview transcripts on written request to UWE Bristol
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 19380502Arcangeli 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 22257653Gestaut 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 28409420Chang 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 28237218Dawson 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 14752735Cheng. 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 11847691Kolcaba 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 17099440Braun 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 25158659Goldsworthy 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.
PubMed 37479627
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study Exploring Patient Experiences of Comfort During Radiotherapy and Radiographer Views of Managing Patient Comfort During the Delivery of Radiotherapy
- ClinicalTrials.gov ID
- NCT03984435
- Acronym / sponsor ID
- COMFORT / HAS.19.02.126
- Conditions
- Cancer
- Keywords
- Radiotherapy, Experiences, Comfort management, Patients, Radiographers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Collaborators
- Somerset NHS Foundation Trust
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 15 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A qualitative study exploring patient experiences of comfort during radiotherapy and radiographers' views of managing patient comfort during the delivery of radiotherapy
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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).
- practicing Therapeutic radiographers;
Key exclusion criteria (6 listed)
- patients with treatment delivery time below 10 minutes;
- unable to communicate in English.
- student Therapeutic radiographers,
- no more than two radiographers from the same radiotherapy department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Background: PubMed 19380502Schnur 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.
- Background: PubMed 22257653Arcangeli 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.
- Background: PubMed 28409420Gestaut 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.
- Background: PubMed 28237218Chang 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.
- Background: PubMed 14752735Dawson 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.
- BackgroundCheng. F, Wang.W. Factors influencing comfort level in head and neck neoplasm patients receiving radiotherapy. Int J Nur Scie. 2014; 1 (4): 394-399
- BackgroundCox.J. Davison.A. Comfort as a determiner of treatment position in radiotherapy of the male pelvis. Radiog. 2005; 11 (2): 109-115
- BackgroundGoldsworthy.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
- BackgroundPineau,C. The psychological meaning of comfort. International Review of Applied Psychology. 1982. Vol 31, 271-283
- Background: PubMed 11847691Kolcaba K, Steiner R. Empirical evidence for the nature of holistic comfort. J Holist Nurs. 2000 Mar;18(1):46-62. doi: 10.1177/089801010001800106.
- Background: PubMed 17099440Kolcaba 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.
- BackgroundBraun V. Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology; 2006 July 3: 77-101
- COMFORT study Twitter accountLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Access to anonymised interview transcripts on written request to UWE Bristol
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon D Goldsworthy, MSc principal investigator
Principal Research Radiographer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of the West of England at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon D Goldsworthy, MSc (01823 344250, Simon.goldsworthy@tst.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences of comfort during radiotherapy - qualitative (non-standard outcome measure) (time frame: Duration of radiotherapy and up to three months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03984435, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.