Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire

Study Overview
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Brief Summary
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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).

Detailed Description
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At the first visit all patients included in the study were asked to complete the Croatian version of the Voice Handicap Index (VHI), Short Form Health Survey (SF-36) and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR) questionnaire. SECEL 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 the Likert scale (0-never, 1-sometimes, 2-often, 3-always). 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), and 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, and the higher score indicates greater difficulties and worse postoperative speech-communication adjustment. The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and also scored with Likert scale with overall score from 0 to 120. Higher scores indicate a greater handicap. The Short Form Health Survey (SF-36) is a multi-purpose short-form health survey that consist of 36 questions divided in eight scales and clustered into two groups: physical and mental health. Each item was standardized (range 0-100), with a higher score representing better QoL. The objective assessment includes the maximum phonation time measured in seconds as common clinical measure of glottal efficiency, diadochokinesis of the 3-syllable pa-ta-ka in 5 seconds (rated in syll/s) or how quickly subjects can produce a series of rapid sounds which is a measure of speech efficiency. All patients will fulfil the SECEL:HR questionnaire twice, two weeks after the initial test and that will be considered as a re-test of the SECEL reliability analysis.

Official Title
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Validation and Cross-cultural Adaptation of Croatian Self-Evaluation of Communication Experiences After Laryngectomy Questionnaire

Conditions
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Larynx Neoplasm, Laryngectomy; Status, Communication, Quality of Life

Intervention / Treatment
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* Behavioral: Quality of life questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult laryngectomised patients<br>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 | Behavioral: Quality of life questionnaire<br>* Filling out questionnaires, measuring maximum phonation and diadochokinesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyse the reliability of the Croatian version of the SECEL (SECEL:HR) questionnaire. | 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 the Likert scale (0-never, 1-sometimes, 2-often, 3-always) | 15 minutes- required to complete the questionnaire | 
| Relationship between the Croatian version of the SECEL and generic QOL questionnaire Short Form Health Survey (SF-36) | Completing the Croatian version of the Short Form Health Survey (SF-36) questionnaire. The Short Form Health Survey consist of 36 questions divided in eight scales and clustered into two groups: physical and mental health. Each item is standardized (range 0-100), with a higher score representing better QoL. | 15 minutes- required to complete the questionnaire | 
| Relationship between the Croatian version of the SECEL and voice-related QOL questionnaire Voice Handicap Index (VHI) | Completing the Croatian version of the Voice Handicap Index (VHI) questionnaire. The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and scored with Likert scale (0-never, 1-almost never, 2-sometimes, 3-almost always, 4-always) with overall score from 0 to 120. | 10 minutes- required to complete the questionnaire | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between maximum phonation time (MPT) and SECEL: HR. | The maximum phonation time (measured in seconds) for which a person can sustain a vowel sound when produced on 1 deep breath at a comfortable pitch and loudness and is a common clinical measure of glottal efficiency. | 5 minutes | 
| Relationship between diadochokinesis and SECEL: HR. | The diadochokinesis measures how quickly an individual can accurately produce a series of rapid sounds of the 3-syllable pa-ta-ka in 5 seconds (rated in syll/s) and is a measure of speech efficiency. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngectomy, Speech,alaryngeal, Quality of Life, Assessment, Communication