Efficacy of a guided self-help exercise program targeting speech, swallowing and shoulder problems in laryngectomized patients: a randomized controlled trial
Completed
- Conditions
- head and neck cancerlaryngeal cancer10038666
- Registration Number
- NL-OMON43884
- Lead Sponsor
- KNO/hoofd-halschirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients treated with total laryngectomy in the last 5 years
Exclusion Criteria
Patients treated with total laryngectomy combined with a total glossectomy, patients treated with a partial laryngectomy, patients younger than 18 years, patients with cognitive impairments or who do not understand the Dutch language.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measures are differences in swallowing quality (swallowing<br /><br>quality of life questionnaire), speech problems (speech handicap index) and<br /><br>shoulder disability (shoulder disability questionnaire) between the<br /><br>intervention and control group at follow-up measurements. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are generic and head and neck cancer specific<br /><br>quality of life (EORTC quality of life core module and head and neck cancer<br /><br>module), the incremental cost effectiveness ratio (calculated using different<br /><br>cost questionnaires and the EuroQol-5 dimensions) and self-management (patients<br /><br>activation measure).</p><br>