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Recruiting NCT06662929

Arabic PRO Measures for Head and Neck Cancer Radiotherapy.

— Observational Head and Neck Cancer Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Oropharynx Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation.
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study

Overview

The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Validation of these PROM tools will allow clinicians to identify the concerns related to our patient population and measure the outcome of our interventions. Main objectives are: * To further validate (cross-culture) the PROM instruments related to head and neck cancer (HNC) in Arabic patients. * To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics. The participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.

Interventions

  • Radiation Radiation
    Radiotherapy for the Head \& Neck Cancer

Primary outcome measures

  • Summated Xerostomia Inventory (SXI) [Time frame: 24 months]
  • Patient-Reported Oral Mucositis Symptom (PROM) scale [Time frame: 24 months]
  • The Arabic University of Washington questionnaire (UW-QOL v4) [Time frame: 24 months]
  • The Arabic Brief Fatigue Inventory (ArBFI) [Time frame: 24 months]
  • Patient Concerns Inventory - Head and Neck (PCI-HNC) [Time frame: 24 months]
Secondary outcome measures (1)
  • To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics. [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 or above and who is planned for receiving and who is currently receiving and who had already received radiotherapy for the HNC at King Saud University Medical City.

Exclusion criteria

  • Individuals who are less than 18 years, presence of debilitating disease (e.g. heart failure) or who lack the capacity to read, understand and sign the informed consent and those.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Saudi Arabia · 1 center
  • King Saud University Medical City — Riyadh

Publications

  • Aguilar ML, Sandow P, Werning JW, Brenneman L, Psoter WJ. The Head and Neck Cancer Patient Concern Inventory(c) : Patient Concerns' Prevalence, Dental Concerns' Impact, and Relationships of Concerns with Quality of Life Measures. J Prosthodont. 2017 Apr;26(3):186-195. doi: 10.1111/jopr.12496. Epub 2017 Feb 21. PMID 28220985
  • Alhazzazi TY, Alghamdi FT. Head and Neck Cancer in Saudi Arabia: a Systematic Review. Asian Pac J Cancer Prev. 2016;17(8):4043-8. PMID 27644659
  • Alqaryan S, Aldrees T, Almatrafi S, Alharbi A, Alhumaid H. Awareness of head and neck cancers in Saudi Arabia. A questionnaire based study. Saudi Med J. 2020 Apr;41(4):400-405. doi: 10.15537/smj.2020.4.24990. PMID 32291427
  • Berger AM, Abernethy AP, Atkinson A, Barsevick AM, Breitbart WS, Cella D, Cimprich B, Cleeland C, Eisenberger MA, Escalante CP, Jacobsen PB, Kaldor P, Ligibel JA, Murphy BA, O'Connor T, Pirl WF, Rodler E, Rugo HS, Thomas J, Wagner LI. NCCN Clinical Practice Guidelines Cancer-related fatigue. J Natl Compr Canc Netw. 2010 Aug;8(8):904-31. doi: 10.6004/jnccn.2010.0067. No abstract available. PMID 20870636
  • Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013 Jan 28;346:f167. doi: 10.1136/bmj.f167. PMID 23358487
  • Catania G, Bell C, Ottonelli S, Marchetti M, Bryce J, Grossi A, Costantini M. Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI). Support Care Cancer. 2013 Feb;21(2):413-9. doi: 10.1007/s00520-012-1539-z. Epub 2012 Jul 13. PMID 22790224
  • Cruz FM, Munhoz BA, Alves BC, Gehrke FS, Fonseca FL, Kuniyoshi RK, Cubero D, Peppone LJ, Del Giglio A. Biomarkers of fatigue related to adjuvant chemotherapy for breast cancer: evaluation of plasma and lymphocyte expression. Clin Transl Med. 2015 Feb 14;4:4. doi: 10.1186/s40169-015-0051-8. eCollection 2015. PMID 25852820
  • Dirix P, Nuyts S, Van den Bogaert W. Radiation-induced xerostomia in patients with head and neck cancer: a literature review. Cancer. 2006 Dec 1;107(11):2525-34. doi: 10.1002/cncr.22302. PMID 17078052

Identifiers

NCT: NCT06662929 · E-23-7571

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗