- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04265326
Validity and Reliability of the Turkish Version of the Head and Neck Cancer Inventory
September 1, 2021 updated by: Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
165
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
18 years to 80 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
- Patients diagnosed with head and neck cancer
Exclusion Criteria:
- Patients whose health conditions are too bad to fill the scale
- Having a serious mental disorder or dementia
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 Head and Neck Cancer Inventory 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 |
---|---|---|
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].
|
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
|
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].
|
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
- 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. Erratum In: CA Cancer J Clin. 2016 Jul;66(4):351.
- Funk 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.
- Heutte 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.
- Gliklich 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.
- D'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.
- 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.
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 8, 2020
First Posted (Actual)
February 11, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-146
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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