NCT04265326

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

1.6 years

First QC Date

February 8, 2020

Last Update Submit

September 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4

    At baseline

Study Arms (1)

Head and Neck Cancer patients

Turkish patients diagnosed with Head and Neck Cancer

Other: Measurement of Quality of Life

Interventions

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

Head and Neck Cancer patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Turkish patients diagnosed with head and neck patients

You may qualify if:

  • Voluntarily accepting to participate in the study
  • Patients whose native language is Turkish
  • Patients diagnosed with head and neck cancer

You may not qualify if:

  • Patients whose health conditions are too bad to fill the scale
  • Having a serious mental disorder or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kadirhan Ozdemir

Izmir, 06580, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 27002678BACKGROUND
  • 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.

    PMID: 12808660BACKGROUND
  • 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.

    PMID: 24291153BACKGROUND
  • 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.

    PMID: 9278754BACKGROUND
  • 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.

    PMID: 8615964BACKGROUND
  • 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.

    PMID: 8635098BACKGROUND
  • 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.

    PMID: 14678568BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Central Study Contacts

Kadirhan Ozdemir, PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Geriatric Rehabilitation Department

Study Record Dates

First Submitted

February 8, 2020

First Posted

February 11, 2020

Study Start

March 13, 2020

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations