Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Sep 16;6(1):98.
doi: 10.1186/s41687-022-00507-1.

Translation, linguistic validation and reliability of FACT-H&N questionnaire in Oral Cancer patients in Sudan

M El Sheikh  1 , A Suleiman  2 , A Satti  3 , E M O'Sullivan  4
Affiliations

Translation, linguistic validation and reliability of FACT-H&N questionnaire in Oral Cancer patients in Sudan

M El Sheikh et al. J Patient Rep Outcomes. .

Abstract

Background: This study aimed to translate and validate an Arabic version of the Functional Assessment of Cancer Therapy Head and Neck Scale (FACT-H&N, v-4) for use among Sudanese oral cancer patients.

Methods: The instrument underwent translation and validation following the standard FACT translation methodology. The translated instrument was pre-tested for face validity and content validity using semi-structured, in-depth interviews with ten oral cancer patients to assess acceptability. The questionnaire was pilot tested with 60 patients; reliability was tested for internal consistency with Cronbach's alpha while construct validity was tested using 'known-group validity'.

Results: The pre-test study revealed no major issues, apart from a reluctance to answer questions on sexual satisfaction. The FACT-H&N demonstrated good internal consistency, it considered five particular constructs: PWB, SWB, EWB, FWB and FACT-H&N, their Cronbach's α values were positive and close to 1 with values of 0.85, 0.788, 0.86, 0.895 and 0.703 respectively, indicating that the questionnaire was valid and the responses consistent. Sixty patients were asked the global health-related quality of life item, 36.3% rated their QOL as very good or good (36.3%), while 41.7% rated it as average, and 21.7% as poor or very poor. Then FACT subscale mean scores were tabulated against three categories; patients with very poor/poor recorded significantly lower scores indicating construct validity. Some psychometric properties were consistent with other FACT-H&N translations such as the Chinese, French, Pakistani and Malaysian.

Conclusions: This study validates the Arabic version of the FACT-H&N. It is a reliable tool and, will assist further QoL research in other Arabic-speaking countries.

Keywords: Arabic; FACT-H&N; Head and neck cancer; Oral cancer; Quality of life (QoL); Sudan; Translation.

Plain language summary

While survival rates are routinely used to evaluate treatment outcomes in oral cancer, increased understanding of the human cost of this disease highlights the need to also consider the impact of the disease and therapy on patients’ quality of life (QoL). Measurement of quality of life outcomes requires a validated QoL questionnaire with proven applicability in that specific context. Little research has been undertaken on the QoL of cancer patients in Sudan and no published research exists to date on the QoL of Sudanese oral cancer patients. While an Arabic version of the FACT-G general questionnaire exists, the FACT-H&N module was not previously available in Arabic. This paper describes the translation of the FACT-H&N from English into Arabic to suit Sudanese patients and other Arabic-speaking patients, with a detailed pre-test review by 10 patients, a pilot study with 60 patients and further validation with 130 patients. This study represents the first QoL research undertaken in oral cancer patients in Sudan and provides some insight into the impact of oral cancer on their lives. Findings from this study indicate that the Arabic version of the FACT-H&N questionnaire is a valid, reliable and acceptable method for assessing health related QoL in Arabic-speaking Sudanese oral cancer patients. This work will benefit future researchers working with Arabic-speaking oral cancer patients.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

References

    1. De Cicco D, Tartaro G, Ciardiello F, Fasano M, Rauso R, Fiore F, Spuntarelli C, Troiano A, Lo Giudice G, Colella G. Health-related quality of life in oral cancer patients: scoping review and critical appraisal of investigated determinants. Cancers (Basel) 2021;13(17):4398. doi: 10.3390/cancers13174398. - DOI - PMC - PubMed
    1. de Melo NB, de Sousa VM, Bernardino IM, de Melo DP, Gomes DQ, Bento PM. Oral health related quality of life and determinant factors in patients with head and neck cancer. Med Oral Pathol Oral Cir Bucal. 2019;24(3):e281–e289. doi: 10.4317/medoral.22670. - DOI - PMC - PubMed
    1. 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;6(12):2918–31. doi: 10.1002/cam4.1221. - DOI - PMC - PubMed
    1. Bakshi J, Kumar A, Saini GJ. Quality of life in oral cancer patients following surgical excision and flap reconstruction. J Maxillofac Oral Surg. 2021 doi: 10.1007/s12663-020-01499-5. - DOI - PMC - PubMed
    1. Murphy BA, Ridner S, Wells N, Dietrich M. Quality of life research in head and neck cancer: a review of the current state of the science. Crit Rev Oncol/Hematol. 2007;62(3):251–267. doi: 10.1016/j.critrevonc.2006.07.005. - DOI - PubMed

LinkOut - more resources