Clinical trial · Observational
Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire
Validation and Cross-cultural Adaptation of Croatian Self-Evaluation of Communication Experiences After Laryngectomy Questionnaire
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Communication | — | UNRESOLVED | — |
| Laryngectomy; Status | — | UNRESOLVED | — |
| Larynx Neoplasm | Laryngeal Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of life questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult laryngectomised patients
- description
- Patients who have undergone total laryngectomy and completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
- interventionNames
- Behavioral: Quality of life questionnaire
Primary outcomes (3)
- measure
- Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire
- timeFrame
- 15 minutes- required to complete the questionnaire
- description
- Completing the Croatian version of the SECEL questionnaire. Questionnaire consists of two parts. The first part examines the relevant general data on the person filling out the questionnaire, while the second part consists of 35 items questionably or statement-designed to examine communication experiences. Patients estimates the incidence of these communication difficulties on a 4-point scale (0-never, 1-sometimes, 2-often, 3-always) The 35 items are grouped according to 3 subscales named General (0-15 score range), Environment (0-42 score range) and Attitude (0-45 score range). Item number 35 is a separate question: "Do you talk the same amount now as before your laryngectomy?" and is rated with a "yes," "more," and "less" rating category. The overall numerical score varies from 0 to 102, where the higher score indicates greater difficulties and worse postoperative speech-communication adjustment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy 2. Patients with preserved reading skills 3. Regular presence at follow-up visits Exclusion Criteria: 1. Acute respiratory infection of the upper or lower respiratory tract 2. Presence of neurologic or pulmonary diseases 3. Recurrence of cancer 4. Deviation from the research protocol
References
Publications (7)
- BACKGROUNDSchindler A, Mozzanica F, Brignoli F, Maruzzi P, Evitts P, Ottaviani F. Reliability and validity of the Italian self-evaluation of communication experiences after laryngeal cancer questionnaire. Head Neck. 2013 Nov;35(11):1606-15. doi: 10.1002/hed.23198. Epub 2012 Nov 20. PMID 23169480
- BACKGROUNDFinizia C, Bergman B, Lindstrom J. A cross-sectional validation study of Self-Evaluation of Communication Experiences after Laryngeal Cancer--a questionnaire for use in the voice rehabilitation of laryngeal cancer patients. Acta Oncol. 1999;38(5):573-80. doi: 10.1080/028418699431159. PMID 10427945
- BACKGROUNDLundstrom E, Hammarberg B. Speech and voice after laryngectomy: perceptual and acoustical analyses of tracheoesophageal speech related to voice handicap index. Folia Phoniatr Logop. 2011;63(2):98-108. doi: 10.1159/000319740. Epub 2010 Oct 8. PMID 20938189
- BACKGROUNDJohansson M, Ryden A, Finizia C. Self evaluation of communication experiences after laryngeal cancer - a longitudinal questionnaire study in patients with laryngeal cancer. BMC Cancer. 2008 Mar 27;8:80. doi: 10.1186/1471-2407-8-80. PMID 18371189
- BACKGROUNDBonetti A, Bonetti L. Cross-cultural adaptation and validation of the Voice Handicap Index into Croatian. J Voice. 2013 Jan;27(1):130.e7-130.e14. doi: 10.1016/j.jvoice.2012.07.006. Epub 2012 Oct 6. PMID 23044461
- BACKGROUNDMaslic Sersic D, Vuletic G. Psychometric evaluation and establishing norms of Croatian SF-36 health survey: framework for subjective health research. Croat Med J. 2006 Feb;47(1):95-102. PMID 16489702
- DERIVEDLaksar Klaric Z, Danic Hadzibegovic A, Vceva A, Karadza Lapic L, Babler D, Kralik K, Bonetti A, Bensic A. Validation and Cross-Cultural Adaptation of Croatian Self-Evaluation of Communication Experiences after Laryngectomy Questionnaire. Folia Phoniatr Logop. 2023;75(5):273-283. doi: 10.1159/000529771. Epub 2023 Feb 17.