Clinical trial NCT05346237: Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire
Official title: Validation and Cross-cultural Adaptation of Croatian Self-Evaluation of Communication Experiences After Laryngectomy Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Larynx Neoplasm
Laryngectomy; Status
Communication
Quality of Life
Keywords: Laryngectomy
Speech,alaryngeal
Quality of Life
Assessment
Communication
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who have undergone total laryngectomy were included in this study

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.

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

Primary outcomes:
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
measure: Means, Standard Deviations of SF-36
timeFrame: 15 minutes- required to complete the questionnaire
measure: Means, Standard Deviation of VHI Questionnaire
timeFrame: 15 minutes-required to complete the questionnaire
Secondary outcomes:
measure: Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: University Hospital Osijek
Study officials:
affiliation: Clinical Department of ENT and Head and Neck Surgery, Clinical Hospital Centre Osijek
name: Željka Laksar Klarić, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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.