Study protocol for a randomized controlled trial: Prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)

Autor: Ann Goeleven, Sabine Meersschout, Olivier M. Vanderveken, Margot Baudelet, Isabel Hutsebaut, Carl Van Laer, Joost van Dinther, Pol Specenier, Marc Peeters, Sarah Deschuymer, Daan Nevens, Michiel W. M. van den Brekel, Sandra Nuyts, Lisette van der Molen, Caroline Vandenbruaene, F. Duprez, Tom Vauterin, Gwen Van Nuffelen, Hilde Verstraete, Steven Mariën, Leen Van den Steen, Marc De Bodt
Přispěvatelé: ACLC (FGw), Oral and Maxillofacial Surgery
Jazyk: angličtina
Rok vydání: 2020
Předmět:
medicine.medical_specialty
Time Factors
medicine.medical_treatment
Medicine (miscellaneous)
law.invention
Study Protocol
03 medical and health sciences
(Chemo)radiotherapy
0302 clinical medicine
Belgium
Randomized controlled trial
Swallowing
Quality of life
law
Medicine and Health Sciences
medicine
otorhinolaryngologic diseases
Humans
Multicenter Studies as Topic
Pharmacology (medical)
030223 otorhinolaryngology
Randomized Controlled Trials as Topic
Protocol (science)
lcsh:R5-920
Prophylactic swallowing exercises
business.industry
digestive
oral
and skin physiology
Head and neck cancer
Chemoradiotherapy
Dysphagia
medicine.disease
Head-and-neck cancer
Deglutition
Exercise Therapy
Radiation therapy
Treatment Outcome
Head and Neck Neoplasms
Adherence
030220 oncology & carcinogenesis
Quality of Life
Physical therapy
Human medicine
medicine.symptom
lcsh:Medicine (General)
Deglutition Disorders
Complication
business
Zdroj: Trials, 21:237. BioMed Central
Trials
Trials, 21(1):237. BioMed Central
TRIALS
Trials, Vol 21, Iss 1, Pp 1-10 (2020)
ISSN: 1745-6215
Popis: Background Dysphagia is a common and serious complication after (chemo)radiotherapy (CRT) for head-and-neck cancer (HNC) patients. Prophylactic swallowing exercises (PSE) can have a significantly positive effect on post-treatment swallowing function. However, low adherence rates are a key issue in undermining this positive effect. This current randomized trial will investigate the effect of adherence-improving measures on patients’ swallowing function, adherence and quality of life (QOL). Methods This ongoing trial will explore the difference in adherence and swallowing-related outcome variables during and after PSE in HNC patients performing the same therapy schedule, receiving different delivery methods. One hundred and fifty patients treated in various hospitals will be divided into three groups. Group 1 performs PSE at home, group 2 practices at home with continuous counseling through an app and group 3 receives face-to-face therapy by a speech and language pathologist. The exercises consist of tongue-strengthening exercises and chin-tuck against resistance with effortful swallow. The Iowa Oral Performance Instrument and the Swallowing Exercise Aid are used for practicing. Patients are evaluated before, during and after treatment by means of strength measurements, swallowing and QOL questionnaires. Discussion Since low adherence rates undermine the positive impact of PSE on post-treatment swallowing function, there is need to develop an efficient PSE protocol maximizing adherence rates. Trial registration ISRCTN, ID: ISRCTN98243550. Registered retrospectively on 21 December 2018.
Databáze: OpenAIRE
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