Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346237
• Other study ID #: OsijekUH-SECEL
• Status: Recruiting
• Start date: October 7, 2021
• Est. completion date: November 2023

Study information

• Verified date: August 2022
• Source: Osijek University Hospital
• Contact: Željka Laksar Klaric, M.D.
• Phone: +38598666494
• Email: zeljka.l.klaric[@]mail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: November 2023
• Est. primary completion date: June 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Communication
• Laryngeal Neoplasms
• Laryngectomy; Status
• Quality of Life

Intervention

Behavioral:
• Quality of life questionnaire
Filling out questionnaires, measuring maximum phonation and diadochokinesis

Locations

Country	Name	City	State
Croatia	University Hospital Osijek	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Osijek University Hospital

Country where clinical trial is conducted

Croatia, 

References & Publications (6)

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. — View Citation

Finizia C, Bergman B, Lindström 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. — View Citation

Johansson M, Rydén 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. — View Citation

Lundström 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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