OncologyH&NPRER-RACNCT04543045
Qualitative Exploration of Head & Neck Cancer Patient Reported Experience of Radiotherapy
An observational study of Oncology and Head and Neck Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study aims to explore the experience of patients with Head and Neck Cancer, who are preparing for and/or completed radiotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Head and Neck Cancer, Anxiety
- What is being tested?
- not an intervention
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2021to Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Range of patients who have completed or partially completed radiotherapy treatment utilising a mask. This will include a range of patients (i) those who's records indicate, or patients report that they experienced severe difficulties tolerating the mask, (ii) those who could not complete the full course of radiotherapy; and (iii) those who experienced no difficulties at all.
Who may be able to join
- Aged over 18 (no upper age limit)
- Completed or partially completed radiotherapy treatment utilising a mask ≥ 6 weeks previous to study entry
Who cannot join
- Unable to understand and communicate in the English language
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Daisy Hopper contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation
Manchester, m20 4bx
Jacqui Stringer, Dr, +441619182439, jacqui.stringer3@nhs.net
About this study
Official title: Qualitative Exploration of Head & Neck Cancer Patient Reported Experience of Radiotherapy With Focus on Restriction Anxiety & 'Claustrophobia
The study aims to explore the experience of patients with Head and Neck Cancer, who are preparing for and/or completed radiotherapy treatment.
Read the detailed description
This is a non-interventional study using interviews to explore head and neck cancer patients' experience of preparing for and completing radiotherapy utilising an immobilisation mask.
The study will be conducted in 2 stages:
The first stage is Item generation. Approximately 20 interviews will be conducted with head and neck cancer patients who have completed or partially completed radiotherapy. The interviews will capture their experiences and views pertaining to mould making, scans and radiotherapy, reported associated fear of restriction, suffocation, loss of control and fear of public embarrassment during treatment.
The data from the interviews will be used to develop potential items for a screening tool for identification of those patients likely to experience anxiety and claustrophobia before they start their treatment.
The second stage is cognitive interviews. Approximately 5 patients included in Stage I will be invited to take part in a further interview to review the themes and potential questionnaire items identified from interviews.
- Conditions
- Oncology, Head and Neck Cancer, Anxiety
- Being tested
- not an intervention
- Keywords
- patient experience, claustrophobia, radiotherapy, radiotherapy moulds, radiotherapy masks
- Medical subject headings
- Neoplasms, Head and Neck Neoplasms, Anxiety Disorders, Claustrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not an interventionOther
not an intervention
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | 20 patients will be interviewed once, which will be approximately 60 minutes in duration. The interviews will be audio recorded. Receives: Other: not an intervention | |
| Stage 2 | Five patients who participated in stage 1 will take part in a cognitive interview, which will be approximately 60 minutes in duration.The interviews will be audio recorded. Receives: Other: not an intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experience
Interviews will be used to generate themes that capture the patients experience. These themes are the primary outcome.There are no units of measurement or data collection tools only an interview schedule.
Measured: within 6 weeks of using a mask
Secondary outcomes (1)
potential items for a questionnaire
interviews extracts will be used as potential item for the interview
Measured: 2 months after completing or partially completing radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start5 May 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqui Stringer, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543045
- Sponsor's protocol ID
- CFTSp182
- Acronym
- H&NPRER-RAC
- Status last verified
- Mar 2023
- First submitted
- 30 Jul 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Exploration of Head & Neck Cancer Patient Reported Experience of Radiotherapy With Focus on Restriction Anxiety & 'Claustrophobia
- ClinicalTrials.gov ID
- NCT04543045
- Acronym / sponsor ID
- H&NPRER-RAC / CFTSp182
- Conditions
- Oncology, Head and Neck Cancer, Anxiety
- Keywords
- patient experience, claustrophobia, radiotherapy, radiotherapy moulds, radiotherapy masks
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 9 Sep 2020 (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.
The study aims to explore the experience of patients with Head and Neck Cancer, who are preparing for and/or completed radiotherapy treatment.
Detailed description
This is a non-interventional study using interviews to explore head and neck cancer patients' experience of preparing for and completing radiotherapy utilising an immobilisation mask.
The study will be conducted in 2 stages:
The first stage is Item generation. Approximately 20 interviews will be conducted with head and neck cancer patients who have completed or partially completed radiotherapy. The interviews will capture their experiences and views pertaining to mould making, scans and radiotherapy, reported associated fear of restriction, suffocation, loss of control and fear of public embarrassment during treatment.
The data from the interviews will be used to develop potential items for a screening tool for identification of those patients likely to experience anxiety and claustrophobia before they start their treatment.
The second stage is cognitive interviews. Approximately 5 patients included in Stage I will be invited to take part in a further interview to review the themes and potential questionnaire items identified from interviews.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | – | Other: not an intervention20 patients will be interviewed once, which will be approximately 60 minutes in duration. The interviews will be audio recorded. |
| Stage 2 | – | Other: not an interventionFive patients who participated in stage 1 will take part in a cognitive interview, which will be approximately 60 minutes in duration.The interviews will be audio recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Range of patients who have completed or partially completed radiotherapy treatment utilising a mask. This will include a range of patients (i) those who's records indicate, or patients report that they experienced severe difficulties tolerating the mask, (ii) those who could not complete the full course of radiotherapy; and (iii) those who experienced no difficulties at all.
Key inclusion criteria (2 listed)
- Aged over 18 (no upper age limit)
- Completed or partially completed radiotherapy treatment utilising a mask ≥ 6 weeks previous to study entry
Key exclusion criteria (2 listed)
- Unable to understand and communicate in the English language
- Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not an interventionnot an intervention | Other | Stage 1, Stage 2 |
Primary outcome
Patient experience
Time frame: within 6 weeks of using a mask
Interviews will be used to generate themes that capture the patients experience. These themes are the primary outcome.There are no units of measurement or data collection tools only an interview schedule.
1 secondary outcome
potential items for a questionnaire
Time frame: 2 months after completing or partially completing radiotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Daisy Hopper contact
Jacqui Stringer study chair
The Christie NHS Foundation Trust
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 Oncology and Head and Neck Cancer, run by The Christie NHS Foundation Trust 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 2 inclusion and 2 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 14 Mar 2023. 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 Daisy Hopper (daisy.hopper@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient experience (time frame: within 6 weeks of using a mask). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.