Arabic PRO Measures for Head and Neck Cancer Radiotherapy.

NCT06662929 | Recruiting

• 1 other identifier: E-23-7571
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma; Oropharynx Cancer; Nasopharyngeal Cancer; Oral Cancer; Tongue Cancer; Oral Neoplasm

Keywords

PROMs; Head and Neck Cancer; Radiotherapy; COSMIN; Cancer

Outcome Measures

Primary Outcomes (5)

• Summated Xerostomia Inventory (SXI)

  The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.

  24 months

• Patient-Reported Oral Mucositis Symptom (PROM) scale

  The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.

  24 months

• The Arabic University of Washington questionnaire (UW-QOL v4)

  The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.

  24 months

• The Arabic Brief Fatigue Inventory (ArBFI)

  The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.

  24 months

• Patient Concerns Inventory - Head and Neck (PCI-HNC)

  The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.

  24 months

Secondary Outcomes (1)

• To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.

  24 months

Study Arms (1)

Adult aged 18 years or above, and receiving radiotherapy for the HNC.

A non-interventional, questionnaire-based cross-sectional study for Arabic-speaking males and females, aged 18 years or above who is planned for receiving and who is currently receiving and who had already received radiotherapy for the Head \& Neck Cancer at King Saud University Medical City.

Radiation: Radiation

Interventions

Radiation RADIATION

Radiotherapy for the Head \& Neck Cancer

Adult aged 18 years or above, and receiving radiotherapy for the HNC.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Target Population: The study is targeting males and females aged 18 years or above, and receiving radiotherapy for the HNC at the King Saud University Medical City.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University Medical City

Riyadh, Saudi Arabia

RECRUITING

Related Publications (25)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013 Jan 28;346:f167. doi: 10.1136/bmj.f167.

  PMID: 23358487 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Hamilton SN, Tran E, Ho C, Berthelet E, Wu J, DeVries K, LaPointe V, Bowman A, Lagman M, Olson R. Patient-reported outcome measures in patients undergoing radiotherapy for head and neck cancer. Support Care Cancer. 2021 May;29(5):2537-2547. doi: 10.1007/s00520-020-05778-2. Epub 2020 Sep 19.

  PMID: 32949298 BACKGROUND

• Kanatas A, Lowe D, Rogers SN. Health-related quality of life at 3 months following head and neck cancer treatment is a key predictor of longer-term outcome and of benefit from using the patient concerns inventory. Cancer Med. 2022 Apr;11(8):1879-1890. doi: 10.1002/cam4.4558. Epub 2022 Feb 17.

  PMID: 35178880 BACKGROUND

• Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education. 2017;17(4):137-44.

  BACKGROUND

• Kushner JA, Lawrence HP, Shoval I, Kiss TL, Devins GM, Lee L, Tenenbaum HC. Development and validation of a Patient-Reported Oral Mucositis Symptom (PROMS) scale. J Can Dent Assoc. 2008 Feb;74(1):59.

  PMID: 18298885 BACKGROUND

• Mehanna H, Paleri V, West CM, Nutting C. Head and neck cancer--Part 1: Epidemiology, presentation, and prevention. BMJ. 2010 Sep 20;341:c4684. doi: 10.1136/bmj.c4684. No abstract available.

  PMID: 20855405 BACKGROUND

• Mody MD, Rocco JW, Yom SS, Haddad RI, Saba NF. Head and neck cancer. Lancet. 2021 Dec 18;398(10318):2289-2299. doi: 10.1016/S0140-6736(21)01550-6. Epub 2021 Sep 22.

  PMID: 34562395 BACKGROUND

• Okuyama T, Wang XS, Akechi T, Mendoza TR, Hosaka T, Cleeland CS, Uchitomi Y. Validation study of the Japanese version of the brief fatigue inventory. J Pain Symptom Manage. 2003 Feb;25(2):106-17. doi: 10.1016/s0885-3924(02)00596-1.

  PMID: 12590026 BACKGROUND

• Rogers SN, El-Sheikha J, Lowe D. The development of a Patients Concerns Inventory (PCI) to help reveal patients concerns in the head and neck clinic. Oral Oncol. 2009 Jul;45(7):555-61. doi: 10.1016/j.oraloncology.2008.09.004. Epub 2008 Nov 22.

  PMID: 19028135 BACKGROUND

• Senkal HA, Hayran M, Karakaya E, Yueh B, Weymuller EA Jr, Hosal AS. The validity and reliability of the Turkish version of the University of Washington Quality of Life Questionnaire for patients with head and neck cancer. Am J Otolaryngol. 2012 Jul-Aug;33(4):417-26. doi: 10.1016/j.amjoto.2011.10.014. Epub 2011 Dec 1.

  PMID: 22137146 BACKGROUND

• Sharour LA. Translation and Validation of the Arabic Version of the Cancer Needs Questionnaire-Short Form. Asia Pac J Oncol Nurs. 2020 Oct 15;8(1):74-80. doi: 10.4103/apjon.apjon_33_20. eCollection 2021 Jan-Feb.

  PMID: 33426193 BACKGROUND

• Sroussi HY, Epstein JB, Bensadoun RJ, Saunders DP, Lalla RV, Migliorati CA, Heaivilin N, Zumsteg ZS. Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med. 2017 Dec;6(12):2918-2931. doi: 10.1002/cam4.1221. Epub 2017 Oct 25.

  PMID: 29071801 BACKGROUND

• Thomson WM, van der Putten GJ, de Baat C, Ikebe K, Matsuda K, Enoki K, Hopcraft MS, Ling GY. Shortening the xerostomia inventory. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Sep;112(3):322-7. doi: 10.1016/j.tripleo.2011.03.024. Epub 2011 Jul 16.

  PMID: 21684773 BACKGROUND

• Vartanian JG, Carvalho AL, Yueh B, Priante AV, de Melo RL, Correia LM, Kohler HF, Toyota J, Kowalski IS, Kowalski LP. Long-term quality-of-life evaluation after head and neck cancer treatment in a developing country. Arch Otolaryngol Head Neck Surg. 2004 Oct;130(10):1209-13. doi: 10.1001/archotol.130.10.1209.

  PMID: 15492171 BACKGROUND

• Wijers OB, Levendag PC, Braaksma MM, Boonzaaijer M, Visch LL, Schmitz PI. Patients with head and neck cancer cured by radiation therapy: a survey of the dry mouth syndrome in long-term survivors. Head Neck. 2002 Aug;24(8):737-47. doi: 10.1002/hed.10129.

  PMID: 12203798 BACKGROUND

• Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, Bouter LM, de Vet HC. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol. 2010 Mar 18;10:22. doi: 10.1186/1471-2288-10-22.

  PMID: 20298572 BACKGROUND

• Gagnier JJ, Lai J, Mokkink LB, Terwee CB. COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures. Qual Life Res. 2021 Aug;30(8):2197-2218. doi: 10.1007/s11136-021-02822-4. Epub 2021 Apr 5.

  PMID: 33818733 BACKGROUND

• Suleiman K, Al Kalaldeh M, AbuSharour L, Yates B, Berger A, Mendoza T, Malak M, Salameh AB, Cleeland C, Menshawi A. Validation study of the Arabic version of the Brief Fatigue Inventory (BFI-A). East Mediterr Health J. 2019 Nov 25;25(11):784-790. doi: 10.26719/emhj.19.032.

  PMID: 31782514 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms; Nasopharyngeal Neoplasms; Mouth Neoplasms; Tongue Neoplasms; Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Diseases; Mouth Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Abdullah M Alsoghier, PhD

CONTACT

+966114677423; aalsoghier@ksu.edu.sa

Saif A Aljabab, DABR

CONTACT

saljabab@ksu.edu.sa

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Assistant Professor

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 29, 2024
• Study Start: May 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

SA (1)