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

• Conditions: Head and Neck Cancer; Quality of Life

• Registration Number: NCT04265313
• Lead Sponsor: Izmir Bakircay University

Brief 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 . 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 Timeline

• Study First Submitted: 2020-02-08
• Study First Submitted QC: 2020-02-08
• Study First Posted: 2020-02-11
• Study Start: 2020-03-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neck Dissection Impairment Index	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 \[6\].

Secondary Outcome Measures

Name	Time	Method
Modified Constant-Murley Score	At baseline	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. \[10\].
Short Form-36 Health Survey version-2.0	At baseline	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. \[12\].

Trial Locations

Locations (1)

Kadirhan Ozdemir; 🇹🇷 İzmir, Turkey