NCT05346237 · REGISTRY CONDITION SEARCH

Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2025-05-06

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).

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire

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outcome · POSTED

Means, Standard Deviations of SF-36

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outcome · POSTED

Means, Standard Deviation of VHI Questionnaire

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outcome · POSTED

Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
maximum Age: 90 Years
minimum Age: 18 Years
sampling Method: PROBABILITY_SAMPLE
sex: ALL
std Ages: ADULT
OLDER_ADULT
study Population: All patients who have undergone total laryngectomy were included in this study

Treatment arms and interventions

arm Groups

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
intervention Names
Behavioral: Quality of life questionnaire
label
Adult laryngectomised patients

interventions

arm Group Labels
Adult laryngectomised patients
description
Filling out questionnaires, measuring maximum phonation and diadochokinesis
name
Quality of life questionnaire
type
BEHAVIORAL

Study design

observational Model: COHORT
time Perspective: PROSPECTIVE

Enrollment

count: 50
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire
time Frame
15 minutes- required to complete the questionnaire
description
Completing the Croatian version of the Short Form Health Survey (SF-36) questionnaire. The SF-36 consist of 36 questions divided in eight dimension and clustered into two groups: physical and mental health. The 8 groups of questions are: physical functioning (SF-PF), role limitations due to physical problems (SF-RP), bodily pain ( SF-BP), general health (SF-GH), vitality (SF-VT), social functioning (SF-SF), emotional role ( SF-RE), mental health (SF-MH), change in health (SF-HC). To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure
Means, Standard Deviations of SF-36
time Frame
15 minutes- required to complete the questionnaire
description
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, scored on 5-point scale (0-never, 1-almost never, 2-sometimes, 3-almost always, 4-always) with overall score from 0 to 120. Higher scores indicate a greater handicap.
measure
Means, Standard Deviation of VHI Questionnaire
time Frame
15 minutes-required to complete the questionnaire

secondary Outcomes

description
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. Diadochokinesis of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s),and the number of syllables per second of the 5 sentences. Diadochokinesis measures how quickly an individual can accurately produce a series of rapid, alternating sounds and is a simple and common clinical measure of speech efficiency.
measure
Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK)
time Frame
5 minutes

Full study description

brief 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).
detailed Description: 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 dimension 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.

Source references

references

citation
Schindler 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
type
BACKGROUND
citation
Finizia 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
type
BACKGROUND
citation
Lundstrom 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
type
BACKGROUND
citation
Johansson 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
type
BACKGROUND
citation
Bonetti 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
type
BACKGROUND
citation
Maslic 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
type
BACKGROUND
citation
Laksar 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.
pmid
36808105
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice