- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04269148
Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire
September 1, 2021 updated by: Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kadirhan Ozdemir, PhD.
- Phone Number: +905069439059
- Email: kadirhanozdemir@gmail.com
Study Locations
-
-
-
İzmir, Turkey, 06580
- Recruiting
- Kadirhan Ozdemir
-
Contact:
- Kadirhan Ozdemir
- Phone Number: 05069439059
- Email: kadirhanozdemir@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Turkish patients diagnosed with head and neck patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Head and Neck Cancer patients
Turkish patients diagnosed with head and neck cancer
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
McMaster University Head and Neck Radiotherapy Questionnaire
Time Frame: 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].
|
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4
Time Frame: 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).
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
February 8, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 13, 2020
Study Record Updates
Last Update Posted (Actual)
September 2, 2021
Last Update Submitted That Met QC Criteria
September 1, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2018-147
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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