This is a multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands. A parallel cluster design per hospital was selected to prevent contact between participants in the same hospital who are randomised into different study arms. Such contact may result in bias as it may allow for patients in the control arm to be informed about elements of taste steering. To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks. Some hospitals have implemented elements of taste steering. However, these elements are focused on patients who are admitted to the hospital, and therefore only interfere to a limited extent with the present study that is directed at patients managing their taste alterations at home. Experience with the Smaakpupil tool indicates that the algorithm reaches saturation after 3-4 weeks. Therefore, an intervention period of 6 weeks has been selected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
201
To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks.
Amsterdam UMC
Amsterdam, Netherlands
RECRUITINGRijnstate Ziekenhuis
Arnhem, Netherlands
NOT_YET_RECRUITINGVan Weel-Bethesda Ziekenhuis
Dirksland, Netherlands
NOT_YET_RECRUITINGZiekenhuisvoorzieningen Gelderse Vallei
Ede, Netherlands
RECRUITINGUniversity Medical Center Groningen
Groningen, Netherlands
RECRUITINGMartini Ziekenhuis
Groningen, Netherlands
RECRUITINGRadboud University Medical Center
Nijmegen, Netherlands
NOT_YET_RECRUITINGIkazia Ziekenhuis
Rotterdam, Netherlands
RECRUITINGOmmelander Ziekenhuis Groningen
Scheemda, Netherlands
RECRUITINGMaxima Medisch Centrum
Veldhoven, Netherlands
NOT_YET_RECRUITING...and 1 more locations
Food enjoyment in appetite, hunger and sensory perception
Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire (AHSP) after 6 weeks of taste steering compared with standard care. The AHSP uses a 5-point Likert scale (1-5), with higher scores indicating greater appetite, hunger, or sensory changes.
Time frame: 6 weeks
Food enjoyment and liking
Food enjoyment and food liking: questions on food enjoyment and food liking on 9-point hedonic scale. Higher scores on the Food enjoyment and food liking indicate more food enjoyment and food liking.
Time frame: 6 weeks
Health-related quality of life
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30 questionnaire) assesses quality of life. It is measured using 1-4 and 1-7 scales. Higher scores indicate better functioning and global quality of life, and worse symptoms on symptom domains.
Time frame: 6 weeks
Taste and smell alterations
The Chemotherapy-induced Taste Alteration Scale (ciTAS-NL) assesses taste and smell alterations across intensity, discomfort, and phantogeusia/parageusia domains. It is measured using a 5-point Likert scale. Higher scores indicate more severe alterations.
Time frame: 6 weeks
Risk of malnutrition
The Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) assesses the risk of malnutrition. It is measured using patient-reported items scored numerically. Scores of 0-3 indicate low risk, 4-8 moderate risk, and ≥9 high risk of malnutrition, with higher scores reflecting greater need for nutritional intervention.
Time frame: 6 weeks
Dry mouth feeling
Xerostomia Inventory (XI) Assesses the overall subjective experience and frequency of dry mouth symptoms. It is measured using a 5-point Likert scale (1-5). Higher scores indicate more frequent and severe xerostomia. Regional Oral Dryness Inventory (RODI) Assesses the location-specific experience of oral dryness across different regions of the mouth. It is measured using a 5-point Likert scale (1-5). Higher scores indicate more severe regional oral dryness.
Time frame: 6 weeks
Taste and smell function
Taste function measured with taste strips and the smell function measured with Sniffin' Sticks.
Time frame: 6 weeks
Saliva secretion
Saliva secretion
Time frame: 6 weeks
Body weight
Body weight
Time frame: 6 weeks
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