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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:
The participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Radiotherapy for the Head & Neck Cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics. | Descriptive statistics [frequencies with percentage (%) for categorical variables, and the mean (±SD) and median for numerical variables collected] will be used to for patients' demographic and clinical characteristics and study measures using SPSS v.22 (IBM, Armonk, New York). Level of significance will be set at or below 0.05. Correlations between study findings will be assessed using Pearson or Spearman's correlation coefficients - based on normality of data. Regression analyses for patient characteristics and measurement variables. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdullah M Alsoghier, PhD | Contact | +966114677423 | aalsoghier@ksu.edu.sa | |
| Saif A Aljabab, DABR | Contact | saljabab@ksu.edu.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Saud University Medical City | Recruiting | Riyadh | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28220985 | Background | 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. | |
| 27644659 | Background |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009959 | Oropharyngeal Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D014062 | Tongue Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| 24 months |
| 24 months |
| Alhazzazi TY, Alghamdi FT. Head and Neck Cancer in Saudi Arabia: a Systematic Review. Asian Pac J Cancer Prev. 2016;17(8):4043-8. |
| 32291427 | 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. |
| 20870636 | 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. |
| 23358487 | Background | Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013 Jan 28;346:f167. doi: 10.1136/bmj.f167. |
| 22790224 | 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. |
| 25852820 | 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. |
| 17078052 | 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. |
| 32949298 | 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. |
| 35178880 | 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. |
| Background | Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education. 2017;17(4):137-44. |
| 18298885 | 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. |
| 20855405 | 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. |
| 34562395 | 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. |
| 12590026 | 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. |
| 19028135 | 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. |
| 22137146 | 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. |
| 33426193 | 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. |
| 29071801 | 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. |
| 21684773 | 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. |
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| 12203798 | 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. |
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| 31782514 | 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. |
| D009370 | Neoplasms by Histologic Type |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009302 | Nasopharyngeal Diseases |
| D009059 | Mouth Diseases |
| D014060 | Tongue Diseases |