TQ-PAL Development and Validation

Recruiting

• Conditions: Altered Taste

• Registration Number: NCT06588933
• Lead Sponsor: Prof Andrew Davies

Brief Summary

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.

Detailed Description

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."

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To develop a novel assessment tool to assess taste disturbances in patients with advanced cancer	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
To validate the newly developed Taste Questionnaire in Palliative Care (TQ-PAL)	December 2025	To test the TQ-PAL for face, content, construct, convergent and reliability validation.

Trial Locations

Locations (1)

Our Lady's Hospice & Care Services; 🇮🇪 Dublin, Ireland