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

August 7, 2025 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Recurrent Oropharynx Carcinoma

Intervention / Treatment

Other: Treatment for recurrent oropharyngeal cancer (curative/ palliative)

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - London, United Kingdom, SW3 6JJ
    - The Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with a confirmed diagnosis of recurrent, residual or new primary oropharyneal cancer in a previously irradiated field.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Swallowing Related Quality of Life Time Frame: 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	Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing Status Measured Using the 100ml Water Swallow Test Time Frame: 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.	Baseline, 3 months, 6 months
Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS) Time Frame: 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	Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2021

Primary Completion (Actual)

May 13, 2024

Study Completion (Actual)

May 13, 2024

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CCR5242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.