Prospective assessment of swallowing and speech function 10 years after preventive swallowing rehabilitation and chemoradiotherapy for head and neck cancer
Completed
- Conditions
- Functionele beperkingen op het gebied van slikken en spreken.Swallowing and speech impairment
- Registration Number
- NL-OMON44230
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
Inclusion Criteria
Evaluable and disease-free head and neck cancer survivors who participated in the randomized controlled trial regarding a preventive rehabilitation program during chemoradiotherapy, performed ten years ago.
Exclusion Criteria
(suspected) recurrent head and neck cancer
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Objective swallowing outcomes<br /><br>o Videofluoroscopy<br /><br>o Other parameters: tube dependency/nutritional supplements, Functional Oral<br /><br>Intake Scale (FOIS), weight change/BMI, maximal inter-incisal opening (MIO),<br /><br>symptom specific questions, pain (VAS)<br /><br>- Objective speech outcomes<br /><br>o Speech recordings<br /><br>- Subjective outcomes<br /><br>o SWAL-QOL<br /><br>o Voice Handicap Index<br /><br>o Speech Handicap Index<br /><br>o EORTC QLQ-C30 and H&N35<br /><br>o EQ-5D-5L<br /><br>o Study specific questions </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>