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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life questionnaire | Behavioral | Filling out questionnaires, measuring maximum phonation and diadochokinesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who have undergone total laryngectomy were included in this study
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| Name | Affiliation | Role |
|---|---|---|
| Željka Laksar Klarić, M.D. | Clinical Department of ENT and Head and Neck Surgery, Clinical Hospital Centre Osijek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Osijek | Osijek | 31000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23169480 | Background | 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. | |
| 10427945 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Quality of life questionnaire: Filling out questionnaires, measuring maximum phonation and diadochokinesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Quality of life questionnaire: Filling out questionnaires, measuring maximum phonation and diadochokinesis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes- required to complete the questionnaire |
|
15 minutes
The SECEL is a 35-item patient-reported questionnaire developed to address the communication needs of patients with laryngectomies. The aim was to translate, cross-culturally adapt and validate Croatian version. The SECEL:HR was filled in by 50 laryngectomised patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Quality of life questionnaire: Filling out questionnaires, measuring maximum phonation and diadochokinesis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Željka Laksar Klarić | University hospital Osijek | +38598666494 | zeljka.l.klaric@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2021 | Apr 19, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| D003142 | Communication |
| D013060 | Speech |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 15 minutes-required to complete the questionnaire |
| 5 minutes |
| 20938189 | 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. |
| 18371189 | 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. |
| 23044461 | 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. |
| 16489702 | 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. |
| 36808105 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Tumor stage | Tumor stage -primary tumor T1 - the tumor is limited to the vocal cords with normal mobility T2 - the tumor spreads to the supraglottis and/or subglottis or a tumor with limited mobility of the vocal cords T3 - the tumor is confined to the larynx with fixation of the vocal cords T4- the tumor invades the thyroid or cricoid cartilage or affects tissue outside the larynx | Count of Participants | Participants |
|
| Smoking habits | Count of Participants | Participants |
|
| Time since surgery | Count of Participants | Participants |
|
| Radiotherapy | Count of Participants | Participants |
|
| Chemotherapy | Count of Participants | Participants |
|
| Education completed | Count of Participants | Participants |
|
| OG000 | SECEL:HR = General Subscale | General subscale - questions or statements, intended to examine communication experiences. Patients estimate the incidence of these communication difficulties on the Likert scale (0-never, 1-sometimes, 2-often, 3-always). General (0-15 score range), |
| OG001 | SECEL:HR = Environment Subscale | Environment subscale - questions or statements, intended to examine communication experiences. Patients estimate the incidence of these communication difficulties on the Likert scale (0-never, 1-sometimes, 2-often, 3-always). Environment subscale (0-42 score range). |
| OG002 | SECEL:HR = Attitude Subscale | Attitude subscale - questions or statements, intended to examine communication experiences. Patients estimate the incidence of these communication difficulties on the Likert scale (0-never, 1-sometimes, 2-often, 3-always). Attitude subscale (0-45 score range) |
| OG003 | SECEL:HR = Total | 35 items designed as questions or statements and intended to examine communication experiences. Patients estimate the incidence of these communication difficulties on the Likert 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) |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes- required to complete the questionnaire |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 15 minutes-required to complete the questionnaire |
|
|
|
| Secondary | Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK) | 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. | Posted | Mean | Standard Deviation | mesured in seconds | 5 minutes |
|
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| D001519 | Behavior |
| D014705 | Verbal Behavior |