Assessing the Dutch-language version of a questionnaire designed to assess the impact of the side effects of radiotherapy in patients with head and neck cancer
Not Applicable
Completed
- Conditions
- Patients with head and neck cancer treated with radiotherapy, surgery, chemoradiotherapy or a combination of the before mentioned treatment modalitiesCancer
- Registration Number
- ISRCTN12923581
- Lead Sponsor
- Antwerp University Hospital
- Brief Summary
2022 Results article in http://www.b-ent.be/Content/files/sayilar/104/BENT_October_2022-254-261.pdf (added 22/01/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Patients with head and neck cancer treated with radiotherapy or chemoradiotherapy; tumor located in the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx
2. Patients with head and neck cancer treated with surgery; tumor located in the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx
3. The treatment was completed at least 6 months ago
4. Aged 18 years or older
5. Without any cognitive disorders
Exclusion Criteria
Does not meet inclusion criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Dysphagia-related quality of life (QoL) and the patient's own view of his/her swallowing problems and the resulting limitations in activities and participation, assessed using the Dutch-Head and Neck Cancer Survivors’ Assessment of Mealtimes (D-HNSAM) (patient questionnaire) at baseline and after 1 week <br>2. Swallowing-related quality of life assessed using the Dysphagia Handicap Index (DHI) (patient questionnaire) at baseline<br>3. Objective and subjective rehabilitation participation assessed using the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (patient questionnaire) at baseline<br>4. Normality of diet, eating in public, and speech intelligibility assessed using the Performance Status Scale - Head and Neck Cancer (PSS-HN) (clinician-based interview) at baseline<br>5. Oral intake capabilities assessed using the Functional Oral Intake Scale (FOIS) (clinician-based interview) at baseline
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures