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OpenTrials
Completed

NCT Number: NCT04952922

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

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.

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Key information

Conditions

Recurrent Oropharynx Carcinoma Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Treatment for recurrent oropharyngeal cancer (curative/ palliative)

Other

Open salvage surgery, transoral robotic surgery, palliative chemotherapy, immunotherapy.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

  • Imperial College London

Registry information

Acronym: FUNQOLR

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2021
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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