Qualitative Exploration of Head & Neck Cancer Patient Reported Experience of Radiotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Qualitative Exploration of Head & Neck Cancer Patient Reported Experience of Radiotherapy With Focus on Restriction Anxiety & 'Claustrophobia

Conditions
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Oncology, Head and Neck Cancer, Anxiety

Intervention / Treatment
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* Other: not an intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18 (no upper age limit) Completed or partially completed radiotherapy treatment utilising a mask ≥ 6 weeks previous to study entry Exclusion Criteria: Unable to understand and communicate in the English language Unable to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage 1<br>20 patients will be interviewed once, which will be approximately 60 minutes in duration. The interviews will be audio recorded. | Other: not an intervention<br>* not an intervention<br>|
| Stage 2<br>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. | Other: not an intervention<br>* not an intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 6 weeks of using a mask | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| potential items for a questionnaire | interviews extracts will be used as potential item for the interview | 2 months after completing or partially completing radiotherapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient experience, claustrophobia, radiotherapy, radiotherapy moulds, radiotherapy masks