NCT04265313

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".

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

1.6 years

First QC Date

February 8, 2020

Last Update Submit

September 1, 2021

Conditions

Quality of LifeHead and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 \[6\].

    At baseline

Secondary Outcomes (2)

  • Modified Constant-Murley Score

    At baseline

  • Short Form-36 Health Survey version-2.0

    At baseline

Study Arms (1)

Head and Neck Cancer patients

Turkish patients diagnosed with Head and Neck Cancer

Other: Measurement of Quality of Life

Interventions

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.

Head and Neck Cancer patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Turkish patients diagnosed with head and neck patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kadirhan Ozdemir

Izmir, 06580, Turkey (Türkiye)

RECRUITING

Related Publications (12)

  • 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.

    PMID: 4051117BACKGROUND

  • 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.

    PMID: 2258287BACKGROUND

  • 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.

    PMID: 1833491BACKGROUND

  • 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.

    PMID: 6625099BACKGROUND

  • 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.

    PMID: 14477989BACKGROUND

  • 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.

    PMID: 11784253BACKGROUND

  • 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.

    PMID: 18218327BACKGROUND

  • 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.

    PMID: 11124729BACKGROUND

  • 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.

    PMID: 24291153BACKGROUND

  • 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.

    PMID: 26854052BACKGROUND

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

    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.

    PMID: 27866914BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Central Study Contacts

Kadirhan Ozdemir, PhD.

CONTACT

+905069439059kadirhanozdemir@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Geriatric Rehabilitation Department

Study Record Dates

First Submitted

February 8, 2020

First Posted

February 11, 2020

Study Start

March 13, 2020

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations

TU(1)