Validity and Reliability of the Turkish Version of the Neck Dissection Impairment Index

NCT ID: NCT04265313

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-13

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Quality of Life Head and Neck Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Head and Neck Cancer patients

Turkish patients diagnosed with Head and Neck Cancer

Measurement of Quality of Life

Intervention Type OTHER

Quality of life will be measured using The Neck Dissection Impairment Index, Modified Constant-Murley Score, Short Form-36 Health Survey version-2.0.

Interventions

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Measurement of Quality of Life

Quality of life will be measured using The Neck Dissection Impairment Index, Modified Constant-Murley Score, Short Form-36 Health Survey version-2.0.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role collaborator

Izmir Bakircay University

OTHER

Sponsor Role lead

Responsible Party

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Kadirhan Ozdemir, PT, PhD.

Head of Geriatric Rehabilitation Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kadirhan Ozdemir

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kadirhan Ozdemir, PhD.

Role: CONTACT

+905069439059

Facility Contacts

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Kadirhan Ozdemir

Role: primary

05069439059

References

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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.

Reference Type BACKGROUND
PMID: 4051117 (View on PubMed)

Soo 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.

Reference Type BACKGROUND
PMID: 2258287 (View on PubMed)

Shone 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.

Reference Type BACKGROUND
PMID: 1833491 (View on PubMed)

Leipzig 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.

Reference Type BACKGROUND
PMID: 6625099 (View on PubMed)

NAHUM 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.

Reference Type BACKGROUND
PMID: 14477989 (View on PubMed)

Taylor 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.

Reference Type BACKGROUND
PMID: 11784253 (View on PubMed)

Constant 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.

Reference Type BACKGROUND
PMID: 18218327 (View on PubMed)

Ware 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.

Reference Type BACKGROUND
PMID: 11124729 (View on PubMed)

Heutte 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.

Reference Type BACKGROUND
PMID: 24291153 (View on PubMed)

Celik 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.

Reference Type BACKGROUND
PMID: 26854052 (View on PubMed)

Ware, J., M. Kosinski, and J. Dewey, How to score version 2 of the SF-36 health survey. Lincoln, RI: Quality Incorporated, 2000.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 27866914 (View on PubMed)

Other Identifiers

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2018-145

Identifier Type: -

Identifier Source: org_study_id

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