Validity and Reliability of the Turkish Version of the Head and Neck Cancer Inventory

Quality of Life Clinical Trial

Official title:

Validity and Reliability of the Turkish Version of the Head and Neck Cancer Inventory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265326
• Other study ID #: 2018-146
• Status: Recruiting
• Start date: March 13, 2020
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: Izmir Bakircay University
• Contact: Kadirhan Ozdemir, PhD.
• Phone: +905069439059
• Email: kadirhanozdemir[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Quality of Life

Intervention

Other:
• Measurement of Quality of Life
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

Locations

Country	Name	City	State
Turkey	Kadirhan Ozdemir	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Bakircay University	Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. Review. Erratum in: CA Cancer J Clin. 2016 Jul;66(4):351. — View Citation

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. — View Citation

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. — View Citation

Gliklich RE, Goldsmith TA, Funk GF. Are head and neck specific quality of life measures necessary? Head Neck. 1997 Sep;19(6):474-80. — View Citation

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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	At baseline
Secondary	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].	At baseline