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

• Conditions: Quality of Life; Head and Neck Cancer
• Interventions: Other: Measurement of Quality of Life

• Registration Number: NCT04269148
• Lead Sponsor: Izmir Bakircay University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-08
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• 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: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head and Neck Cancer patients	Measurement of Quality of Life	Turkish patients diagnosed with head and neck cancer

Primary Outcome Measures

Name	Time	Method
McMaster University Head and Neck Radiotherapy Questionnaire	At baseline	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 \[1\].

Secondary Outcome Measures

Name	Time	Method
The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4	At baseline	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).

Trial Locations

Locations (1)

Kadirhan Ozdemir; 🇹🇷 İzmir, Turkey