N/A
N=50
Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire
Larynx Neoplasm · Laryngectomy; Status · Communication · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT05346237 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire — 4.69; 16.33; 9.38; 30.10 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Quality of life questionnaire (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Osijek University Hospital
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire |
4.69; 16.33; 9.38; 30.10; 4.21; 14.85 | — |
| PRIMARY Means, Standard Deviations of SF-36 |
75.50; 60.00; 77.20; 62.60; 68.20; 78.38 | — |
| PRIMARY Means, Standard Deviation of VHI Questionnaire |
7.50; 15.84; 12.70; 35.86 | — |
| SECONDARY Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK) |
8.55; 8.94 | — |
Summary
Self-Evaluation of Communication Experiences after Laryngectomy (SECEL) questionnaire has been developed, with the aim of evaluating rehabilitation needs and the psychosocial care for patients with laryngeal cancer. This short but comprehensive self-report instrument measures the perceived adjustment to communication experiences and is intended to aid in determining counselling needs in patients with laryngeal cancer who are treated with a laryngectomy. The first aim of this study is to evaluate the translation, psychometric properties and cultural adaptation of a Croatian version of the SECEL questionnaire. Secondary aim is to examine relationship between the Croatian version of the SECEL and the Short Form Health Survey (SF-36) and the Voice Handicap Index (VHI) questionnaires and to examine relationship between objective voice measures and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR).
Eligibility Criteria
Inclusion Criteria
- Patients who completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
- Patients with preserved reading skills
- Regular presence at follow-up visits
Exclusion Criteria
- Acute respiratory infection of the upper or lower respiratory tract
- Presence of neurologic or pulmonary diseases
- Recurrence of cancer
- Deviation from the research protocol
Data sourced from ClinicalTrials.gov (NCT05346237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.