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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04269148
• Other study ID #: 2018-147
• Status: Recruiting
• Start date: March 13, 2020
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: Izmir Bakircay University
• Contact: Kadirhan Ozdemir, PhD.
• Phone: +905069439059
• Email: kadirhanozdemir[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Although there are various surveys in the literature that evaluate the quality of life of head and neck cancer patients, apart from the "McMaster University Head and Neck Radiotherapy Questionnaire", there is no other questionnaire designed specifically for local advanced stage III and stage IV head and neck cancer and treatment of specific morbidity at a certain time. Patients in these stages often have difficulties in oral communication, nutritional disorders and loss of chewing and swallowing skills leading to dehydration, bad mouth odors, appearance problems affecting social and family life, and often significant morbidity including severe pain symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• The patient does not have sufficient functions of bone marrow, liver and kidney

• To have scored less than 70 from Karnofsky Performance Scale

Related Conditions & MeSH terms

• Head and Neck Cancer
• Quality of Life

Intervention

Other:
• Measurement of Quality of Life
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

Locations

Country	Name	City	State
Turkey	Kadirhan Ozdemir	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Bakircay University	Gazi University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4	This scale consists of 5 categories that evaluate physical (7 items), social (7 items), emotional (6 items), functional status (7 items) and a subscale consisting of 11 questions specifically developed for head and neck cancer. In this assessment consisting of 38 items in total, each field can be scored among themselves and a total score is also calculated. The increase in the total score shows that the quality of life is higher. Each item is scored by patients with a Likert type classification ranging from 0 (none) to 4 (too many).	At baseline