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NCT Number: NCT06588933

TQ-PAL Development and Validation

Taste problems are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. There is no validated tool to assess taste disturbances and their impact on patients with advanced cancer. This study will develop and validate a novel assessment tool to assess taste disturbances and their impact on patients with advanced cancer.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Patients with advanced cancer often develop taste disturbances. A recent literature review reported a median prevalence of 55%, with prevalence ranging from 27-93%. Studies have shown taste disturbance is usually a persistent symptom, is often 'moderate-to-severe' in intensity, and is often associated with significant distress. Taste disturbance may have a major impact on the experience and pleasure associated with eating and drinking. Taste disturbance may have a major impact on nutritional intake. It may be associated with low mood / depression, social isolation, and an impaired quality of life.

The aforementioned literature review identified, importantly, that the terminology used in the published literature varied, which may have had an effect on the results obtained, especially prevalence statistics. The review identified the need for "development/validation studies of a taste-specific assessment tool for this group of patients - there is a need for a tool that not only assesses the problem but can also assess the response to treatment for the problem, utilising patient reported outcome measures."

Who can participate

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

Inclusion criteria

18 years of age Diagnosis of locally advanced or metastatic cancer Referred to palliative care/oncology services Taste problems rated 'moderate' or worse over previous 2-week period Good understanding of English

Exclusion criteria

Cognitive impairment (unable to provide consent / complete questionnaire) Taste problems precedes cancer diagnosis. Head and neck surgery Head and neck radiotherapy Salivary gland disorders (e.g., Sjogren's Syndrome) In the 'Deteriorating' or 'Terminal' Phase of illness

Treatment and study plan

completion of a questionnaire

Other

completion of a questionnaire by participant

Primary outcomes

  1. To develop a novel assessment tool to assess taste disturbances in patients with advanced cancer

    Time frame: December 2025

    To develop the Taste Questionnaire in Palliative Care (TQ-PAL) to assess taste disturbances and their impact on patients with palliative care. It's domains include the effect on food intake, social inclusion, and quality of life

  2. To validate the newly developed Taste Questionnaire in Palliative Care (TQ-PAL)

    Time frame: December 2025

    To test the TQ-PAL for face, content, construct, convergent and reliability validation.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Davies, FRCP

CONTACT

[email protected]

014986235

Marie Hannon, BSc

CONTACT

[email protected]

014068720

Sponsors and collaborators

Lead sponsor

Prof Andrew Davies

Other

Registry information

Official study title

The Development and Validation of a Novel Tool for the Assessment of Taste Disturbances in Patients With Advanced Cancer: Taste Questionnaire in Palliative Care

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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