TY - JOUR
T1 - Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)
AU - Member of the Belgian PRESTO Group
AU - van den Steen, Leen
AU - Baudelet, Margot
AU - Duprez, Fréderic
AU - de Bodt, Marc
AU - Deschuymer, Sarah
AU - Goeleven, Ann
AU - Hutsebaut, Isabel
AU - Mariën, Steven
AU - Meersschout, Sabine
AU - Nevens, Daan
AU - Nuyts, Sandra
AU - Peeters, Marc
AU - Specenier, Pol
AU - van den Brekel, Michiel
AU - van der Molen, Lisette
AU - Vandenbruaene, Caroline
AU - Vanderveken, Olivier
AU - van Dinther, Joost
AU - van Laer, Carl
AU - Vauterin, Tom
AU - Verstraete, Hilde
AU - van Nuffelen, Gwen
AU - Belgian PRESTO Group
PY - 2020/3/2
Y1 - 2020/3/2
N2 - 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.
AB - 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.
KW - (Chemo)radiotherapy
KW - Adherence
KW - Dysphagia
KW - Head-and-neck cancer
KW - Prophylactic swallowing exercises
UR - http://www.scopus.com/inward/record.url?scp=85080917586&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-020-4171-0
DO - https://doi.org/10.1186/s13063-020-4171-0
M3 - Article
C2 - 32122397
SN - 1745-6215
VL - 21
JO - Trials
JF - Trials
IS - 1
M1 - 237
ER -