Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire

NCT05346237 | Completed Results

• 1 other identifier: OsijekUH-SECEL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Laryngectomy; Speech,alaryngeal; Quality of Life; Assessment; Communication

Outcome Measures

Primary Outcomes (3)

• Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (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 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.

  15 minutes- required to complete the questionnaire

• Means, Standard Deviations of SF-36

  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.

  15 minutes- required to complete the questionnaire

• Means, Standard Deviation of VHI Questionnaire

  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.

  15 minutes-required to complete the questionnaire

Secondary Outcomes (1)

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

  5 minutes

Study Arms (1)

Adult laryngectomised patients

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

Interventions

Quality of life questionnaire BEHAVIORAL

Filling out questionnaires, measuring maximum phonation and diadochokinesis

Adult laryngectomised patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who have undergone total laryngectomy were included in this study

You may qualify if:

• 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

You may not qualify if:

• Acute respiratory infection of the upper or lower respiratory tract
• Presence of neurologic or pulmonary diseases
• Recurrence of cancer
• Deviation from the research protocol

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

University Hospital Osijek

Osijek, 31000, Croatia

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Laryngeal Neoplasms; Communication; Speech

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Behavior; Verbal Behavior

Results Point of Contact

• Title: Željka Laksar Klarić
• Organization: University hospital Osijek

zeljka.l.klaric@gmail.com

+38598666494

Study Officials

• Željka Laksar Klarić, M.D.

  Clinical Department of ENT and Head and Neck Surgery, Clinical Hospital Centre Osijek

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 26, 2022
• Study Start: October 7, 2021
• Primary Completion: January 9, 2023
• Study Completion: February 8, 2023
• Last Updated: May 6, 2025
• Results First Posted: November 22, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)