Clinical trial NCT04269148: Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire
Official title: Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Head and Neck Cancer
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2020-02-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Turkish patients diagnosed with head and neck patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: McMaster University Head and Neck Radiotherapy Questionnaire
timeFrame: At baseline
Secondary outcomes:
measure: The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4
timeFrame: At baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Kadirhan Ozdemir
Study officials:
References:
citation: 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.
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. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-S.
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. doi: 10.1186/1477-7525-1-79.