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

NCT04543045 | Unknown

• 1 other identifier: CFTSp182
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Head and Neck Cancer; Anxiety

Keywords

patient experience; claustrophobia; radiotherapy; radiotherapy moulds; radiotherapy masks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• potential items for a questionnaire

  2 months after completing or partially completing radiotherapy.

Study Arms (2)

Stage 1

20 patients will be interviewed once, which will be approximately 60 minutes in duration. The interviews will be audio recorded.

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.

Other: not an intervention

Interventions

not an intervention OTHER

not an intervention

Stage 1; Stage 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Aged over 18 (no upper age limit)
• Completed or partially completed radiotherapy treatment utilising a mask ≥ 6 weeks previous to study entry

You may not qualify if:

• Unable to understand and communicate in the English language
• Unable to provide written informed consent

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation

Manchester, m20 4bx, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms; Head and Neck Neoplasms; Anxiety Disorders; Claustrophobia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Mental Disorders; Phobic Disorders

Study Officials

• Jacqui Stringer

  The Christie NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Daisy Hopper

CONTACT

daisy.hopper@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: September 9, 2020
• Study Start: May 5, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)