Communication, Laryngectomy; Status, Larynx Neoplasm, Quality of Life
Conditions
Keywords
Laryngectomy, Speech,alaryngeal, Quality of Life, Assessment, Communication
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.
Interventions
BEHAVIORALQuality of life questionnaire
Filling out questionnaires, measuring maximum phonation and diadochokinesis
Sponsors
Osijek University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | 15 minutes- required to complete the 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. |
| Means, Standard Deviations of SF-36 | 15 minutes- required to complete the questionnaire | 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. |
| Means, Standard Deviation of VHI Questionnaire | 15 minutes-required to complete the 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK) | 5 minutes | 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. |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Adult Laryngectomised Patients |
|---|---|
| Age, Continuous | 66 years |
| Chemotherapy | 18 Participants |
| Education completed Elementary school | 16 Participants |
| Education completed Graduate studies | 1 Participants |
| Education completed High school | 29 Participants |
| Education completed Post-graduate studies | 1 Participants |
| Education completed Undergraduate studies | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Radiotherapy After surgery | 31 Participants |
| Radiotherapy Before surgery | 1 Participants |
| Radiotherapy No | 18 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 48 Participants |
| Smoking habits Ex-smokers | 45 Participants |
| Smoking habits Never smokers | 3 Participants |
| Smoking habits Smokers | 2 Participants |
| Time since surgery 12-24 months | 12 Participants |
| Time since surgery > 24 months | 38 Participants |
| Tumor stage T1- affects a vocal cord with neck metastases in ipsilateral nodes that are no larger than 6 cm | 1 Participants |
| Tumor stage T2 | 9 Participants |
| Tumor stage T3 | 21 Participants |
| Tumor stage T4 | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
Time frame: 15 minutes-required to complete the questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SECEL:HR = General Subscale | Means, Standard Deviation of VHI Questionnaire | 7.50 score on a scale | Standard Deviation 7.6 |
| SECEL:HR = Environment Subscale | Means, Standard Deviation of VHI Questionnaire | 15.84 score on a scale | Standard Deviation 7.6 |
| SECEL:HR = Attitude Subscale | Means, Standard Deviation of VHI Questionnaire | 12.70 score on a scale | Standard Deviation 8.7 |
| SECEL:HR = Total | Means, Standard Deviation of VHI Questionnaire | 35.86 score on a scale | Standard Deviation 19.9 |
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.
Time frame: 15 minutes- required to complete the questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SECEL:HR = General Subscale | Means, Standard Deviations of SF-36 | 75.50 units on a scale | Standard Deviation 16.2 |
| SECEL:HR = Environment Subscale | Means, Standard Deviations of SF-36 | 60.00 units on a scale | Standard Deviation 41.3 |
| SECEL:HR = Attitude Subscale | Means, Standard Deviations of SF-36 | 77.20 units on a scale | Standard Deviation 26.1 |
| SECEL:HR = Total | Means, Standard Deviations of SF-36 | 62.60 units on a scale | Standard Deviation 15.8 |
| SF-VT | Means, Standard Deviations of SF-36 | 68.20 units on a scale | Standard Deviation 18.2 |
| SF-SF | Means, Standard Deviations of SF-36 | 78.38 units on a scale | Standard Deviation 20.6 |
| SF-RE | Means, Standard Deviations of SF-36 | 78.02 units on a scale | Standard Deviation 37.9 |
| SF-MH | Means, Standard Deviations of SF-36 | 72.88 units on a scale | Standard Deviation 19.6 |
| SF-HC | Means, Standard Deviations of SF-36 | 56.00 units on a scale | Standard Deviation 22.3 |
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.
Time frame: 15 minutes- required to complete the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SECEL:HR = General Subscale | Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | Re- Test (standard deviation) | 4.69 units on a scale | Standard Deviation 2.7 |
| SECEL:HR = General Subscale | Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | Test (standard deviation) | 4.21 units on a scale | Standard Deviation 2.4 |
| SECEL:HR = Environment Subscale | Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | Test (standard deviation) | 14.85 units on a scale | Standard Deviation 2.4 |
| SECEL:HR = Environment Subscale | Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | Re- Test (standard deviation) | 16.33 units on a scale | Standard Deviation 8.4 |
| SECEL:HR = Attitude Subscale | Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | Re- Test (standard deviation) | 9.38 units on a scale | Standard Deviation 8.8 |
| SECEL:HR = Attitude Subscale | Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | Test (standard deviation) | 7.49 units on a scale | Standard Deviation 7 |
| SECEL:HR = Total | Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | Re- Test (standard deviation) | 30.10 units on a scale | Standard Deviation 17.5 |
| SECEL:HR = Total | Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire | Test (standard deviation) | 26.51 units on a scale | Standard Deviation 14.1 |
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.
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SECEL:HR = General Subscale | Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK) | 8.55 mesured in seconds | Standard Deviation 4.2 |
| SECEL:HR = Environment Subscale | Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK) | 8.94 mesured in seconds | Standard Deviation 2 |