Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer

Completed

• Conditions: Recurrent Oropharynx Carcinoma

• Registration Number: NCT04952922
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

The purpose of this research project is to measure changes in communication, swallowing and quality of life and individual patient priorities which may happen over time in patients with a diagnosis of recurrent head and neck cancer, specifically recurrent cancer (cancer which has returned after previous treatment) of the back of the throat, the tonsils and/or the base of tongue (recurrent oropharyngeal cancer) and what it is like for patients and their significant others to experience these changes over time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-07-07
• Study Start: 2021-10-27
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13
• Results First Submitted: 2025-03-18
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Results First Posted: 2025-08-08
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Adult (aged 18 years or over) competent to provide consent
• Have a diagnosis of recurrent OPC
• Have adequate linguistic and cognitive function to participate in interview
• English speaking

Exclusion Criteria

• Any previous medical condition, other than HNC, which has a known impact on communication/ swallowing (Parkinson's Disease, Multiple Sclerosis, cerebral vascular accident (CVA)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Reported Swallowing Related Quality of Life	Baseline, 3 months, 6 months	Performance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores; Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public; Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head \& neck related symptoms); Total score Scale 0 -100, a higher score indicating better performance/higher quality of life; The score reported is the combined score with the total being the sum of the sub-scale scores

Secondary Outcome Measures

Name	Time	Method
Swallowing Status Measured Using the 100ml Water Swallow Test	Baseline, 3 months, 6 months	The Water Swallow Test is used to monitor swallow performance and possible aspiration - patients are viewed to have failed the test if they cough, have a wet voice quality post swallow or are unable to complete the task.
Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS)	Baseline, 3 months, 6 months	The scale consists of 8 levels (0-7) where drinks are measured as 0-4 to describe thickness (0 being thin, 4 being extremely thick) and foods are measured as 3-7 (3 being liquidised, 7 being regular/easy to chew); A higher score indicates a higher level of swallowing function, 0 being the lowest score, 7 being the highest score

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom