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

September 1, 2021 updated by: Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
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".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Turkish patients diagnosed with head and neck patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Head and Neck Cancer patients
Turkish patients diagnosed with Head and Neck Cancer
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Constant-Murley Score
Time Frame: 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].
At baseline
Short Form-36 Health Survey version-2.0
Time Frame: 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].
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Bakircay University

Collaborators

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 8, 2020

First Submitted That Met QC Criteria

February 8, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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