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

Anxiety Clinical Trial

— H&NPRER-RAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543045
• Other study ID #: CFTSp182
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: September 2023

Study information

• Verified date: March 2023
• Source: The Christie NHS Foundation Trust
• Contact: Daisy Hopper
• Email: daisy.hopper[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Head and Neck Cancer
• Head and Neck Neoplasms
• Oncology

Intervention

Other:
• not an intervention
not an intervention

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	potential items for a questionnaire	interviews extracts will be used as potential item for the interview	2 months after completing or partially completing radiotherapy.