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

Recruiting

• Conditions: Anxiety; Oncology; Head and Neck Cancer
• Interventions: Other: not an intervention

• Registration Number: NCT04543045
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

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 Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2021-05-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage 1	not an intervention	20 patients will be interviewed once, which will be approximately 60 minutes in duration. The interviews will be audio recorded.
Stage 2	not an intervention	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.

Primary Outcome Measures

Name	Time	Method
Patient experience	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.

Secondary Outcome Measures

Name	Time	Method
potential items for a questionnaire	2 months after completing or partially completing radiotherapy.	interviews extracts will be used as potential item for the interview

Trial Locations

Locations (1)

The Christie NHS Foundation; 🇬🇧 Manchester, United Kingdom