Quality of LifeNCT04265326
Validity and Reliability of the Turkish Version of the Head and Neck Cancer Inventory
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
The primary treatment option of many patients with head and neck cancer is surgery, radiotherapy and chemotherapy. In the literature, functional problems that occur after surgical interventions applied to head and neck cancer patients are frequently mentioned. 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
- 165 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
- Patients diagnosed with head and neck cancer
Who cannot join
- Patients whose health conditions are too bad to fill the scale
- Having a serious mental disorder or dementia
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
The primary treatment option of many patients with head and neck cancer is surgery, radiotherapy and chemotherapy. In the literature, functional problems that occur after surgical interventions applied to head and neck cancer patients are frequently mentioned. Morbidities resulting from the combined application of radiotherapy and chemotherapy are based on more anecdotal information and critical data on long-term functional outcomes in this patient group are scarce. The aim of this study is to make the validity, reliability and cultural adaptation of the Head and Neck Cancer Inventory in Turkish.
Read the detailed description
In the literature, there are general cancer scales developed to evaluate the quality of life of head and neck cancer patients and sub scales associated with head and neck cancers developed in addition to these scales. In addition, scales specific to head and neck cancers have also been developed. However, previous research shows that even general health status scales or cancer-specific scales cannot determine outcomes related to many head and neck cancer patients. In addition, items containing multiple functions and patients' attitudes (behaviors) cannot be analyzed separately in any of the scales specific to head and neck cancer. Very few surveys contain items related to patients' attitudes (behaviors), or the number of items related to this topic is small because most of these scales are functional items. Unlike its counterparts in the literature, Head and Neck Cancer Inventory evaluates the attitudes (behaviors) of patients associated with various functions in daily life. Head and Neck Cancer Inventory is the only scale in the literature that contains the basic features of the health conditions declared by the patient and has been developed specifically for head and neck cancer.
- 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 Head and Neck Cancer Inventory 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.
Head and Neck Cancer Inventory
It is a scale consisting of 30 items in total, containing 4 main categories [speech (10 items), eating (10 items), aesthetics (2 items), social disorders (7 items)] evaluating the quality of life related to head and neck cancer and an additional item evaluating the overall quality of life. This inventory reflects both functionality (how functional the patient is) and attitudes (how satisfied is the patient's functional level) using a 5-point Likert-type scale. This scale does not have a summary score representing all items, the score of 4 different categories can be calculated. The higher the scores, the better the quality of life [2].
Measured: At baseline
Secondary outcomes (1)
The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4
In addition to the 27-item Cancer Treatment Functional Evaluation-General (FACT-G) scale, this scale consists of 9 additional items specific to head and neck cancer. FACT G consists of 4 main categories that evaluate physical (7 items), social (7 items), emotional (6 items) and functional status (7 items). Each item is scored by patients with a Likert type classification ranging from 0 (none) to 4 (too many). Points are calculated separately for each category. A summary score is also calculated for FACT-G and total FACT-H \& N [3]. The questionnaire is available in Turkish version [9].
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 posted11 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 (7)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
- 165 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
- NCT04265326
- Sponsor's protocol ID
- 2018-146
- 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
Cohen EE, LaMonte SJ, Erb NL, Beckman KL, Sadeghi N, Hutcheson KA, Stubblefield MD, Abbott DM, Fisher PS, Stein KD, Lyman GH, Pratt-Chapman ML. American Cancer Society Head and Neck Cancer Survivorship Care Guideline. CA Cancer J Clin. 2016 May;66(3):203-39. doi: 10.3322/caac.21343. Epub 2016 Mar 22.
PubMed 27002678Funk GF, Karnell LH, Christensen AJ, Moran PJ, Ricks J. Comprehensive head and neck oncology health status assessment. Head Neck. 2003 Jul;25(7):561-75. doi: 10.1002/hed.10245.
PubMed 12808660Heutte N, Plisson L, Lange M, Prevost V, Babin E. Quality of life tools in head and neck oncology. Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Feb;131(1):33-47. doi: 10.1016/j.anorl.2013.05.002. Epub 2013 Nov 28.
PubMed 24291153Gliklich RE, Goldsmith TA, Funk GF. Are head and neck specific quality of life measures necessary? Head Neck. 1997 Sep;19(6):474-80. doi: 10.1002/(sici)1097-0347(199709)19:63.0.co;2-w.
PubMed 9278754D'Antonio LL, Zimmerman GJ, Cella DF, Long SA. Quality of life and functional status measures in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 1996 May;122(5):482-7. doi: 10.1001/archotol.1996.01890170018005.
PubMed 8615964List 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 Head and Neck Cancer Inventory
- ClinicalTrials.gov ID
- NCT04265326
- Acronym / sponsor ID
- 2018-146
- Conditions
- Quality of Life, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 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
- 11 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.
The primary treatment option of many patients with head and neck cancer is surgery, radiotherapy and chemotherapy. In the literature, functional problems that occur after surgical interventions applied to head and neck cancer patients are frequently mentioned. Morbidities resulting from the combined application of radiotherapy and chemotherapy are based on more anecdotal information and critical data on long-term functional outcomes in this patient group are scarce. The aim of this study is to make the validity, reliability and cultural adaptation of the Head and Neck Cancer Inventory in Turkish.
Detailed description
In the literature, there are general cancer scales developed to evaluate the quality of life of head and neck cancer patients and sub scales associated with head and neck cancers developed in addition to these scales. In addition, scales specific to head and neck cancers have also been developed. However, previous research shows that even general health status scales or cancer-specific scales cannot determine outcomes related to many head and neck cancer patients. In addition, items containing multiple functions and patients' attitudes (behaviors) cannot be analyzed separately in any of the scales specific to head and neck cancer. Very few surveys contain items related to patients' attitudes (behaviors), or the number of items related to this topic is small because most of these scales are functional items. Unlike its counterparts in the literature, Head and Neck Cancer Inventory evaluates the attitudes (behaviors) of patients associated with various functions in daily life. Head and Neck Cancer Inventory is the only scale in the literature that contains the basic features of the health conditions declared by the patient and has been developed specifically for head and neck cancer.
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 (3 listed)
- Voluntarily accepting to participate in the study
- Patients whose native language is Turkish
- Patients diagnosed with head and neck cancer
Key exclusion criteria (2 listed)
- Patients whose health conditions are too bad to fill the scale
- Having a serious mental disorder or dementia
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 Head and Neck Cancer Inventory and The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4 | Other | Head and Neck Cancer patients |
Primary outcome
Head and Neck Cancer Inventory
Time frame: At baseline
It is a scale consisting of 30 items in total, containing 4 main categories [speech (10 items), eating (10 items), aesthetics (2 items), social disorders (7 items)] evaluating the quality of life related to head and neck cancer and an additional item evaluating the overall quality of life. This inventory reflects both functionality (how functional the patient is) and attitudes (how satisfied is the patient's functional level) using a 5-point Likert-type scale. This scale does not have a summary score representing all items, the score of 4 different categories can be calculated. The higher the scores, the better the quality of life [2].
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 27002678Cohen EE, LaMonte SJ, Erb NL, Beckman KL, Sadeghi N, Hutcheson KA, Stubblefield MD, Abbott DM, Fisher PS, Stein KD, Lyman GH, Pratt-Chapman ML. American Cancer Society Head and Neck Cancer Survivorship Care Guideline. CA Cancer J Clin. 2016 May;66(3):203-39. doi: 10.3322/caac.21343. Epub 2016 Mar 22.
- Background: PubMed 12808660Funk GF, Karnell LH, Christensen AJ, Moran PJ, Ricks J. Comprehensive head and neck oncology health status assessment. Head Neck. 2003 Jul;25(7):561-75. doi: 10.1002/hed.10245.
- Background: PubMed 24291153Heutte N, Plisson L, Lange M, Prevost V, Babin E. Quality of life tools in head and neck oncology. Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Feb;131(1):33-47. doi: 10.1016/j.anorl.2013.05.002. Epub 2013 Nov 28.
- Background: PubMed 9278754Gliklich RE, Goldsmith TA, Funk GF. Are head and neck specific quality of life measures necessary? Head Neck. 1997 Sep;19(6):474-80. doi: 10.1002/(sici)1097-0347(199709)19:63.0.co;2-w.
- Background: PubMed 8615964D'Antonio LL, Zimmerman GJ, Cella DF, Long SA. Quality of life and functional status measures in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 1996 May;122(5):482-7. doi: 10.1001/archotol.1996.01890170018005.
- 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 3 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?
Head and Neck Cancer Inventory (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 NCT04265326, which also lists 7 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.