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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 and smell training.
To examine the effect of at-home taste and smell training versus standard care on taste function and other outcome parameters, measurements will take place at baseline (before the training starts), and after 12 weeks. The intervention 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taste and smell training | Experimental | To examine the effect of at-home taste and smell training versus standard care on taste function and other outcome parameters, measurements will take place at baseline (before the training starts), and after 12 weeks. The intervention will take place at home. |
|
| No intervention | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taste and smell training | Behavioral | To examine the effect of at-home taste and smell training versus standard care on taste function and other outcome parameters, measurements will take place at baseline (before the training starts), and after 12 weeks. The intervention 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Taste function | Taste function measured with taste strips at baseline and after week 12 weeks of taste and smell training compared with standard care | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Smell function | Smell function measured with Sniffin' Sticks at baseline and after week 12 of taste and smell training compared to standard care | 12 weeks |
| Food enjoyment | Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire and the Food enjoyment and food liking: questions on food enjoyment and food liking on 9-point hedonic scale at baseline and after 12 weeks of taste and smell training compared with standard care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J. J.A. de Haan, MD, PhD | Contact | +31 50 361 2821 | j.j.de.haan@umcg.nl | |
| M. D. Douma | Contact | +31 50 361 4603 | m.d.douma@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| J. J.A. de Haan, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D013649 | Taste |
| D000094562 | Olfactory Training |
| ID | Term |
|---|---|
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D013812 | Therapeutics |
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| 12 weeks |
| Quality of life | Quality of life: EORTC QLQ-C30 | 12 weeks |
| Taste and smell alterations | Taste and smell alterations: Chemotherapy-induced Taste Alteration Scale (ciTAS-NL) | 12 weeks |
| Risk of malnutrition | Risk of malnutrition: Patient-Generated Subjective Global Assessment (PG-SGA) | 12 weeks |
| Dry mouth feeling | Dry mouth feeling: Xerostomia Inventory (XI) and Regional Oral Dryness Inventory (RODI) | 12 weeks |
| Saliva secretion | Saliva secretion | 12 weeks |
| Body weight | Body weight | 12 weeks |
| Rijnstate Ziekenhuis | Not yet recruiting | Arnhem | Netherlands |
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| Van Weel-Bethesda Ziekenhuis | Not yet recruiting | Dirksland | Netherlands |
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| Ziekenhuisvoorzieningen Gelderse Vallei | Recruiting | Ede | Netherlands |
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| University Medical Center Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
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| Martini Ziekenhuis | Recruiting | Groningen | Netherlands |
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| Radboud University medical Center | Not yet recruiting | Nijmegen | Netherlands |
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| Ikazia Ziekenhuis | Recruiting | Rotterdam | Netherlands |
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| Ommelander Ziekenhuis Groningen | Recruiting | Scheemda | Netherlands |
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| Maxima Medisch Centrum | Not yet recruiting | Veldhoven | Netherlands |
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| Isala Klinieken | Not yet recruiting | Zwolle | Netherlands |
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