Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire

NCT04269148 | Unknown

• 1 other identifier: 2018-147
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

More than half of the patients with head and neck cancer are locally advanced patients. Radiotherapy is the primary treatment option for many patients with stage III and stage IV diagnosed with head and neck cancer. Radiation often causes tissue reactions by increasing local symptoms of the tumor and adding new symptoms to them. The acute effects of radiation are pain and burns associated with mucosal irritations and skin irritations, the root smell of the necrotic tumor and damaged normal tissues, dry skin, skin irritation, pain and dryness of mucosal membranes, decreased appetite, loss of chewing and swallowing skills, and hoarseness. The aim of this study is to make the validity, reliability and cultural adaptation of McMaster University Head and Neck Radiotherapy Inventory in Turkish.

Conditions

Quality of Life; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• McMaster University Head and Neck Radiotherapy Questionnaire

  McMaster University Head and Neck Radiotherapy Questionnaire: This questionnaire includes 22 questions covering signs and symptoms related to 6 categories: oral cavity, throat, skin, digestive system, energy and psychosocial. n each category, there are at least 3 questions related to that category. There are 7 possible answer options in each question using Likert scale. High scores obtained according to the scoring system used indicate low toxicity. The final score of the survey is expressed as the average of the scores from 22 questions. In addition, the independent scores of each category are the average of the scores from the questions belonging to that category \[1\].

  At baseline

Secondary Outcomes (1)

• The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4

  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 Life OTHER

Quality of life will be measured using McMaster University Head and Neck Radiotherapy Questionnaire and The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4

Head and Neck Cancer patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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
• Undergoing or receiving radiotherapy treatment
• At least 3 weeks have passed since the beginning of radiotherapy

You may not qualify if:

• The patient does not have sufficient functions of bone marrow, liver and kidney
• To have scored less than 70 from Karnofsky Performance Scale

Sponsors & Collaborators

• Izmir Bakircay University: lead
• Gazi University: collaborator

Study Sites (1)

Kadirhan Ozdemir

Izmir, 06580, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Browman GP, Levine MN, Hodson DI, Sathya J, Russell R, Skingley P, Cripps C, Eapen L, Girard A. The Head and Neck Radiotherapy Questionnaire: a morbidity/quality-of-life instrument for clinical trials of radiation therapy in locally advanced head and neck cancer. J Clin Oncol. 1993 May;11(5):863-72. doi: 10.1200/JCO.1993.11.5.863.

  PMID: 8487051 BACKGROUND

• List MA, D'Antonio LL, Cella DF, Siston A, Mumby P, Haraf D, Vokes E. The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity. Cancer. 1996 Jun 1;77(11):2294-301. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-S.

  PMID: 8635098 BACKGROUND

• Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes. 2003 Dec 16;1:79. doi: 10.1186/1477-7525-1-79.

  PMID: 14678568 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Kadirhan Ozdemir, PhD.

CONTACT

+905069439059; kadirhanozdemir@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 13, 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)