Novel questionnaire about oral symptoms ("Oral symptom assessment scale / OSAS), and validated questionnaire about physical and psychological symptoms (Memorial Symptom Assessment Scale / MSAS).

Questionnaire

Andrew Davies, MD

Observational study of prevalence of oral symptoms in patients with advanced cancer using a novel questionnaire ("Oral symptom assessment scale")

A novel questionnaire (the "Oral symptom assessment scale" / OSAS) has been developed to assess a range of oral symptoms in patients with advanced cancer.

The OSAS consists of 20 symptoms, which were chosen following a review of the literature / discussion with experts in the field. The OSAS was modelled on the Memorial Symptom Assessment Scale (MSAS), and asks about the presence of the symptoms, the frequency of the symptoms (i.e. "rarely"; "occasionally"; "frequently"; or "almost constantly"), the severity of the symptoms (i.e. "slight"; "moderate"; "severe"; or "very severe"), and how much distress they cause (i.e. "not at all"; "a little bit"; "somewhat"; "quite a bit"; or "very much"). The questions relate to the last week.

Patients will be given the OSAS to complete, and also the short form of the MSAS (which asks about the presence, and related distress, of 32 physical / psychological symptoms, including a small number of oral symptoms). Demographic data, cancer diagnosis, and performance status will also be collected. The study involves a single visit / assessment.

Descriptive statistics will be used to present the data, and hierarchical cluster analysis will be used to identify oral symptom clusters. Kappa tests will be used to compare analogous questions on the OSAS and short form MSAS (as part of the validation of the OSAS).

Oral Assessment of Symptoms in Advanced Cancer

An Observational Study of the Frequency of Oral Symptoms in Patients With Advanced Cancer

Currently, there are no plans to make IPD available to other researchers

Royal Surrey County Hospital NHS Foundation Trust

Nervous System Diseases

Heart and Blood Diseases

All Conditions

Stroke

A 250 ml feeding pouch containing 400 kcal.

Following the 7-day baseline period, all patients will enter the 28-day intervention period, where they will receive the intervention feed daily. The feed prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management

Bolus Pouch Feed

Rebecca Stratton, PhD

The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.

Bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (HETF) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. However, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

Bolus Pouch Feed Study

A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults

At baseline, and at the mid-point and end of the intervention period, health and feeding related quality of life will be assessed by the FACT-EQ questionnaire.

At baseline, and at the mid-point and end of the intervention period, patients and dietitians will be asked to rate the ease of administering the enteral tube feed via a Likert-style questionnaire. Patients will also count the amount of feeding equipment required to administer the enteral feed at baseline, and at the midpoint and end of the intervention period.

At baseline, and at the mid-point and end of the intervention period, patients will be asked to rate their liking of their usual feeding method or of the intervention feed, respectively via a 7-point Likert scale questionnaire.

A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded at the end of each week. Information about bowel movements will also be collected using the Bristol Stool Chart©.

Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the patient.

At baseline, and at the mid-point and end of the intervention period, the dietitian will conduct a 24-h dietary recall with the patient to record all food, drink and nutritional feeds provided in the 24 h prior. Trained research staff will subsequently analyse all records utilising a nutritional software package (Nutritics Professional v3.09, Nutritics, Ireland) for macro- and micro-nutrient intakes.

At baseline and at the end of the intervention period, body weight (kg) will be measured using standard methods to the nearest 0.1 kg using a weighing scale without heavy clothing.

All adverse events will be recorded throughout the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Assessment of Symptoms in Advanced Cancer	NCT04404920	Oral Complicati... Cancer	Questionnaire	18 Years -	Royal Surrey County Hospital NHS Foundation Trust
Bolus Pouch Feed Study	NCT05822557	Cancer Neurological Di... Gastrointestina... Oral Complicati... Stroke	Bolus Pouch Fee...	16 Years - 100 Years	Nutricia UK Ltd
Bolus Pouch Feed Study	NCT05822557	Cancer Neurological Di... Gastrointestina... Oral Complicati... Stroke	Bolus Pouch Fee...	16 Years - 100 Years	Nutricia UK Ltd

Spots Global Cancer Trial Database for oral complication