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

NCT ID: NCT04265326

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-13

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life Head and Neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Head and Neck Cancer patients

Turkish patients diagnosed with Head and Neck Cancer

Measurement of Quality of Life

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gazi University

OTHER

Sponsor Role collaborator

Izmir Bakircay University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kadirhan Ozdemir, PT, PhD.

Head of Geriatric Rehabilitation Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kadirhan Ozdemir

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kadirhan Ozdemir, PhD.

Role: CONTACT

+905069439059

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kadirhan Ozdemir

Role: primary

05069439059

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27002678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12808660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24291153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9278754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8615964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8635098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14678568 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-146

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Exercise in Head and Neck Cancer Patients
NCT05256238 ACTIVE_NOT_RECRUITING NA