Quality of LifeNCT04265313
Validity and Reliability of the Turkish Version of the Neck Dissection Impairment Index
An observational study of Quality of Life and Head and Neck Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
One of the long-term effects of neck dissection applied to patients with head and neck cancer is shoulder dysfunction, which directly affects the quality of life. Patients complain of different degrees of shoulder joint problems following neck dissection . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Quality of Life, Head and Neck Cancer
- What is being tested?
- Measurement of Quality of Life
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Turkish patients diagnosed with head and neck patients
Who may be able to join
- Voluntarily accepting to participate in the study
- Patients whose native language is Turkish
- Patients or healthy individuals who have completed a minimum 11-month recovery period after selective or modified neck dissection
Who cannot join
- Having a pathological condition in the neck or shoulder that is not related to the treatments associated with head and neck cancer
- Cancer recurrence at the time of the evaluations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kadirhan Ozdemir
Izmir, 06580
Kadirhan Ozdemir, 05069439059, kadirhanozdemir@gmail.com
About this study
One of the long-term effects of neck dissection applied to patients with head and neck cancer is shoulder dysfunction, which directly affects the quality of life. Patients complain of different degrees of shoulder joint problems following neck dissection . Shoulder syndrome in these patients is characterized by a set of symptoms including shoulder pain, abduction limitation, and scapular winging.The aim of this study is to make the Turkish Neck validity, reliability and cultural adaptation of the "Neck Dissection Impairment Index".
Read the detailed description
In the literature, there are many questionnaires aimed at patients with head and neck cancer, developed both specifically and specifically for this patient group, evaluating the quality of life. Regarding the shoulder problems experienced by these patients, there is only one item in the literature called "The University of Michegan Head and Neck QOL (UMHNQOL) questionnaire" that evaluates shoulder pain. Apart from this, there is no other questionnaire in the literature that may adversely affect the quality of life to neck dissection and question both neck and shoulder problems together. The Neck Dissection Impairment Index evaluates the shoulder-related quality of life in a more comprehensive and more detailed manner according to the UMHNQOL questionnaire. The Neck Dissection Impairment Index evaluates the components of shoulder related quality of life in a wide range after neck dissection. Because the type of age, weight, radiotherapy and neck dissection are the most important variables affecting quality of life, patients in the high-risk group (e.g. young individuals, patients who have received radiotherapy and modified radical neck dissection) evaluated with the Neck Dissection Impairment Questionnaire can benefit from an earlier and more intensive rehabilitation.
- Conditions
- Quality of Life, Head and Neck Cancer
- Being tested
- Measurement of Quality of Life
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Quality of LifeOther
Quality of life will be measured using The Neck Dissection Impairment Index, Modified Constant-Murley Score, Short Form-36 Health Survey version-2.0.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Cancer patients | Turkish patients diagnosed with Head and Neck Cancer Receives: Other: Measurement of Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Dissection Impairment Index
It consists of 10 items. Scoring is done according to the 5-point Likert scale. The patients answer the questions in the index as "1 = Not at all, 2 = A little, 3 = A moderate amount, 4 = Quite a bit, 5 = A lot". In order to standardize the obtained raw score over 100 points, the formula "(raw score-10) / 40] × 100" is used. This index evaluates the quality of life associated with neck and shoulder problems that occur in the long term after neck dissection [6].
Measured: At baseline
Secondary outcomes (2)
Modified Constant-Murley Score
It is a modified version of the Constant-Murley score used to evaluate pain, daily life activities, strength, and normal range of motion patency in various shoulder problems. In this test protocol, which is divided into four sub-scales, pain (15 points), daily life activities (20 points), strength (25 points) and normal range of motion (40 points) including flexion, external rotation, abduction and internal rotation movements are scored separately. 100 points in total are tried to be obtained. Pain and daily life activities sub scales in the test protocol will be filled by the patient. Evaluation of force and normal range of motion sub-scales will be done by a physiotherapist using a dynamometer and a goniometer, respectively [7]. Turkish version, validity, reliability and cultural adaptation of the modified Constant-Murley Score test protocol was performed by Celik et al. [10].
Measured: At baseline
Short Form-36 Health Survey version-2.0
It is a questionnaire version in which the instructions in the Short Form 36 (SF-36) questionnaire consisting of 36 questions are developed, the length of the questions are shortened, more familiar, more understandable and simpler words are used, easier to complete, faster to read and reducing the given answers. This questionnaire is a multi-item questionnaire which includes physical functions (10 items), social functions (2 items), role limitations caused by physical problems (3 items), mental health (5 items), energy / fitness (4 items), pain (2 items) and general health perception (5 items) [8]. The score of each item is coded, collected and converted into a scale from 0 to 100 [11]. The Turkish version, validity, reliability and cultural adaptation of the short form-36 Health Status Questionnaire-2.0 were made by Celik et al. [12].
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start13 Mar 2020
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265313
- Sponsor's protocol ID
- 2018-145
- Status last verified
- Sep 2021
- First submitted
- 8 Feb 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sobol S, Jensen C, Sawyer W 2nd, Costiloe P, Thong N. Objective comparison of physical dysfunction after neck dissection. Am J Surg. 1985 Oct;150(4):503-9. doi: 10.1016/0002-9610(85)90164-3.
PubMed 4051117Soo KC, Guiloff RJ, Oh A, Della Rovere GQ, Westbury G. Innervation of the trapezius muscle: a study in patients undergoing neck dissections. Head Neck. 1990 Nov-Dec;12(6):488-95. doi: 10.1002/hed.2880120607.
PubMed 2258287Shone GR, Yardley MP. An audit into the incidence of handicap after unilateral radical neck dissection. J Laryngol Otol. 1991 Sep;105(9):760-2. doi: 10.1017/s0022215100117232.
PubMed 1833491Leipzig B, Suen JY, English JL, Barnes J, Hooper M. Functional evaluation of the spinal accessory nerve after neck dissection. Am J Surg. 1983 Oct;146(4):526-30. doi: 10.1016/0002-9610(83)90246-5.
PubMed 6625099NAHUM AM, MULLALLY W, MARMOR L. A syndrome resulting from radical neck dissection. Arch Otolaryngol. 1961 Oct;74:424-8. doi: 10.1001/archotol.1961.00740030433011. No abstract available.
PubMed 14477989Taylor RJ, Chepeha JC, Teknos TN, Bradford CR, Sharma PK, Terrell JE, Hogikyan ND, Wolf GT, Chepeha DB. Development and validation of the neck dissection impairment index: a quality of life measure. Arch Otolaryngol Head Neck Surg. 2002 Jan;128(1):44-9. doi: 10.1001/archotol.128.1.44.
PubMed 11784253Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.
PubMed 18218327Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
PubMed 11124729Heutte N, Plisson L, Lange M, Prevost V, Babin E. Quality of life tools in head and neck oncology. Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Feb;131(1):33-47. doi: 10.1016/j.anorl.2013.05.002. Epub 2013 Nov 28.
PubMed 24291153Celik D. Turkish version of the modified Constant-Murley score and standardized test protocol: reliability and validity. Acta Orthop Traumatol Turc. 2016;50(1):69-75. doi: 10.3944/AOTT.2016.14.0354.
PubMed 26854052Ware, J., M. Kosinski, and J. Dewey, How to score version 2 of the SF-36 health survey. Lincoln, RI: Quality Incorporated, 2000.
Celik D, Coban O. Short Form Health Survey version-2.0 Turkish (SF-36v2) is an efficient outcome parameter in musculoskeletal research. Acta Orthop Traumatol Turc. 2016 Oct;50(5):558-561. doi: 10.1016/j.aott.2016.08.013. Epub 2016 Nov 17.
PubMed 27866914
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Neck Dissection Impairment Index
- ClinicalTrials.gov ID
- NCT04265313
- Acronym / sponsor ID
- 2018-145
- Conditions
- Quality of Life, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the long-term effects of neck dissection applied to patients with head and neck cancer is shoulder dysfunction, which directly affects the quality of life. Patients complain of different degrees of shoulder joint problems following neck dissection . Shoulder syndrome in these patients is characterized by a set of symptoms including shoulder pain, abduction limitation, and scapular winging.The aim of this study is to make the Turkish Neck validity, reliability and cultural adaptation of the "Neck Dissection Impairment Index".
Detailed description
In the literature, there are many questionnaires aimed at patients with head and neck cancer, developed both specifically and specifically for this patient group, evaluating the quality of life. Regarding the shoulder problems experienced by these patients, there is only one item in the literature called "The University of Michegan Head and Neck QOL (UMHNQOL) questionnaire" that evaluates shoulder pain. Apart from this, there is no other questionnaire in the literature that may adversely affect the quality of life to neck dissection and question both neck and shoulder problems together. The Neck Dissection Impairment Index evaluates the shoulder-related quality of life in a more comprehensive and more detailed manner according to the UMHNQOL questionnaire. The Neck Dissection Impairment Index evaluates the components of shoulder related quality of life in a wide range after neck dissection. Because the type of age, weight, radiotherapy and neck dissection are the most important variables affecting quality of life, patients in the high-risk group (e.g. young individuals, patients who have received radiotherapy and modified radical neck dissection) evaluated with the Neck Dissection Impairment Questionnaire can benefit from an earlier and more intensive rehabilitation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer patients | – | Other: Measurement of Quality of LifeTurkish patients diagnosed with Head and Neck Cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish patients diagnosed with head and neck patients
Key inclusion criteria (3 listed)
- Voluntarily accepting to participate in the study
- Patients whose native language is Turkish
- Patients or healthy individuals who have completed a minimum 11-month recovery period after selective or modified neck dissection
Key exclusion criteria (2 listed)
- Having a pathological condition in the neck or shoulder that is not related to the treatments associated with head and neck cancer
- Cancer recurrence at the time of the evaluations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Quality of LifeQuality of life will be measured using The Neck Dissection Impairment Index, Modified Constant-Murley Score, Short Form-36 Health Survey version-2.0. | Other | Head and Neck Cancer patients |
Primary outcome
Neck Dissection Impairment Index
Time frame: At baseline
It consists of 10 items. Scoring is done according to the 5-point Likert scale. The patients answer the questions in the index as "1 = Not at all, 2 = A little, 3 = A moderate amount, 4 = Quite a bit, 5 = A lot". In order to standardize the obtained raw score over 100 points, the formula "(raw score-10) / 40] × 100" is used. This index evaluates the quality of life associated with neck and shoulder problems that occur in the long term after neck dissection [6].
2 secondary outcomes
Modified Constant-Murley Score
Time frame: At baseline
Short Form-36 Health Survey version-2.0
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Background: PubMed 4051117Sobol S, Jensen C, Sawyer W 2nd, Costiloe P, Thong N. Objective comparison of physical dysfunction after neck dissection. Am J Surg. 1985 Oct;150(4):503-9. doi: 10.1016/0002-9610(85)90164-3.
- Background: PubMed 2258287Soo KC, Guiloff RJ, Oh A, Della Rovere GQ, Westbury G. Innervation of the trapezius muscle: a study in patients undergoing neck dissections. Head Neck. 1990 Nov-Dec;12(6):488-95. doi: 10.1002/hed.2880120607.
- Background: PubMed 1833491Shone GR, Yardley MP. An audit into the incidence of handicap after unilateral radical neck dissection. J Laryngol Otol. 1991 Sep;105(9):760-2. doi: 10.1017/s0022215100117232.
- Background: PubMed 6625099Leipzig B, Suen JY, English JL, Barnes J, Hooper M. Functional evaluation of the spinal accessory nerve after neck dissection. Am J Surg. 1983 Oct;146(4):526-30. doi: 10.1016/0002-9610(83)90246-5.
- Background: PubMed 14477989NAHUM AM, MULLALLY W, MARMOR L. A syndrome resulting from radical neck dissection. Arch Otolaryngol. 1961 Oct;74:424-8. doi: 10.1001/archotol.1961.00740030433011. No abstract available.
- Background: PubMed 11784253Taylor RJ, Chepeha JC, Teknos TN, Bradford CR, Sharma PK, Terrell JE, Hogikyan ND, Wolf GT, Chepeha DB. Development and validation of the neck dissection impairment index: a quality of life measure. Arch Otolaryngol Head Neck Surg. 2002 Jan;128(1):44-9. doi: 10.1001/archotol.128.1.44.
- Background: PubMed 18218327Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.
- Background: PubMed 11124729Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
- Background: PubMed 24291153Heutte N, Plisson L, Lange M, Prevost V, Babin E. Quality of life tools in head and neck oncology. Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Feb;131(1):33-47. doi: 10.1016/j.anorl.2013.05.002. Epub 2013 Nov 28.
- Background: PubMed 26854052Celik D. Turkish version of the modified Constant-Murley score and standardized test protocol: reliability and validity. Acta Orthop Traumatol Turc. 2016;50(1):69-75. doi: 10.3944/AOTT.2016.14.0354.
- BackgroundWare, J., M. Kosinski, and J. Dewey, How to score version 2 of the SF-36 health survey. Lincoln, RI: Quality Incorporated, 2000.
- Background: PubMed 27866914Celik D, Coban O. Short Form Health Survey version-2.0 Turkish (SF-36v2) is an efficient outcome parameter in musculoskeletal research. Acta Orthop Traumatol Turc. 2016 Oct;50(5):558-561. doi: 10.1016/j.aott.2016.08.013. Epub 2016 Nov 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Head and Neck Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kadirhan Ozdemir, PhD. (+905069439059, kadirhanozdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Dissection Impairment Index (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265313, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.