Quality of LifeNCT04269148
Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire
An observational study of Quality of Life and Head and Neck Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Quality of Life, Head and Neck Cancer
- What is being tested?
- Measurement of Quality of Life
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Turkish patients diagnosed with head and neck patients
Who may be able to join
- 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
Who cannot join
- The patient does not have sufficient functions of bone marrow, liver and kidney
- To have scored less than 70 from Karnofsky Performance Scale
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kadirhan Ozdemir
Izmir, 06580
Kadirhan Ozdemir, 05069439059, kadirhanozdemir@gmail.com
About this study
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.
Read the 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.
- Conditions
- Quality of Life, Head and Neck Cancer
- Being tested
- Measurement of Quality of Life
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Quality of LifeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Cancer patients | Turkish patients diagnosed with head and neck cancer Receives: Other: Measurement of Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: At baseline
Secondary outcomes (1)
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).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start13 Mar 2020
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269148
- Sponsor's protocol ID
- 2018-147
- Status last verified
- Sep 2021
- First submitted
- 8 Feb 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8487051List 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.
PubMed 8635098Webster 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.
PubMed 14678568
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire
- ClinicalTrials.gov ID
- NCT04269148
- Acronym / sponsor ID
- 2018-147
- Conditions
- Quality of Life, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer patients | – | Other: Measurement of Quality of LifeTurkish patients diagnosed with head and neck cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish patients diagnosed with head and neck patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- The patient does not have sufficient functions of bone marrow, liver and kidney
- To have scored less than 70 from Karnofsky Performance Scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Quality of LifeQuality 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 | Other | Head and Neck Cancer patients |
Primary outcome
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].
1 secondary outcome
The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Background: PubMed 8487051Browman 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.
- Background: PubMed 8635098List 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.
- Background: PubMed 14678568Webster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Head and Neck Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kadirhan Ozdemir, PhD. (+905069439059, kadirhanozdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McMaster University Head and Neck Radiotherapy Questionnaire (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269148, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.