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FHSI Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index - 8 Item Version For patients with Hepatobiliary cancer (liver, bile duct and pancreas); A FACT-Hepatobiliary Symptom Index (a subset of FACT-Hep containing 8 items) LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details for the FHSI measure: MEASURE NAME: Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index - 8 Item Version (FHSI) VERSION: 4 NUMBER OF ITEMS: 8 PATIENT POPULATION: Hepatobiliary cancer patients 18 years and older RECALL PERIOD: Past 7 days RESPONSE SCALE: 5 point Likert-type scale DATA COLLECTION: Paper and electronic ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Hepatobiliary cancer symptom index TIME FOR COMPLETION: Less than 5 minutes SCORING: Manual scoring template, some items are reverse scored. Total scores possible. SAS/SPSS algorithms available. RELATED MEASURES: FACT-Hep , NFHSI-18 , FACT-G DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FHSI can be obtained by registering for permission. Users are not permitted to translate the FHSI without permission from FACIT.org. Permission from FACIT.org to translate the FHSI may also be contingent upon timeline expectations and availability of FACIT staff. Translations must undergo a rigorous methodology under the guidance of FACIT.org which includes multiple translators, QA steps and cognitive interviews with patients. For commercial use, FACITtrans is the approved translation vendor to translate the FACIT measurement system. Please contact us for more information. VIEW AVAILABLE LANGUAGES Language Availability Licensing Licensing Licensing fees are assessed on a per trial/per measure basis for commercial use. There is no fee for use of the English version, but a license should be obtained. Non-commercial use is assessed on a case-by-case basis. Licensing fees are typically not applied to investigator-initiated research, students, or clinical use. To license an available version of this measure for commercial or non-commercial use, please complete our registration form . All of the information provided in the form will be kept strictly confidential. For questions, please contact us . LICENSE THIS MEASURE Selected References Selected References Cella, D., Paul, D., Yount, S., Winn, R., Chang, C-H, Banik, D., & Weeks, J. What are the most important symptom targets when treating advanced cancer? A survey of providers in the National Comprehensive Cancer Network (NCCN). Cancer Investigation 2003; 21(4): 526-535. doi: 10.108/CNV-120022366. Cella, D., Rosenbloom, S., Beaumont, J., Yount, J., Paul, D., Hampton, D., Abernethy, A., Jacobsen, P., Syrjala, K., & Von Roenn, J. Development and validation of 11 symptom indexes to evaluate response to chemotherapy for advanced cancer. Journal of the National Comprehensive Cancer Network; 2011; 9(3): 268-278. doi: 10.6004/jnccn.2011.0026. Eid, S., Stromberg, A., Ames, S., Ellis, S., McMasters, K., & Martin, R. Assessment of symptom experience in patients undergoing hepatic resection or ablation. Cancer 2006; 107(11): 2715-2722. doi: 10.1002/cncr.22297. Poplin, E., Feng, Y., Berlin, J., Rothenberg, M., Hochster, H., Mitchell, E., Alberts, S., O’Dwyer, P., Haller, D., Catalano, P., Cella, D., & Benson, A. Phase III, Randomized Study of Gemcitabine and Oxaliplatin Versus Gemcitabine (fixed-dose rate infusion) Compared With Gemcitabine (30-minute infusion) in Patients With Pancreatic Carcinoma E6201: A Trial of the Eastern Cooperative Oncology Group. Journal of Clinical Oncolology 2009; 27:3778-3785. doi: 10.1200/JCO.2008.20.900. Yount, S., Cella, D., Webster, K., Heffernan, N., Chang, C.-H., Odom, L., & van Gool, R. Assessment of patient-reported clinical outcome in Pancreatic and other Hepatobiliary Cancers: The FACT Hepatobiliary Symptom Index. Journal of Pain & Symptom Management 2002; 24(1): 32-44. doi: 10.1016/s0885-3924(02)00422-0. Bonomi, A.E., Cella, D.D., Hahn, E.A., Bjordal, K., Sperner, B., Gangeri, L., Bergman, B., Willems, J., Hanquet, P., & Zittoun, R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Quality of Life Research 1996; 5: 309-320. Eremenco, S., Arnold, B., Cella, D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions 2005; 28(2): 212-232. Webster K., Cella D., Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: Properties applications, and interpretation. Health and Quality of Life Outcomes 2003; 1(1): 79-85. Yost K.J., Eton D.T. Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Evaluation & the Health Professions 2005; 28(2): 172-191. LICENSE THIS MEASURE Related Measures Related Measures FACT-Hep Functional Assessment of Cancer Therapy – Hepatobiliary LEARN MORE NFHSI-18 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index - 18 Item Version LEARN MORE FACT-G Functional Assessment of Cancer Therapy – General LEARN MORE

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FACT-Bl-Cys Functional Assessment of Cancer Therapy – Bladder – Cystectomy For patients undergoing cystectomy (formerly FACT-VCI) LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy – Bladder – Cystectomy (FACT-Bl-Cys), originally developed as the FACT – Vanderbilt Cystectomy Index (FACT-VCI), is a condition-specific instrument for patients undergoing radical cystectomy (RC) and urinary diversion (UD) for bladder cancer that measures five domains: Physical, social, emotional, functional well-being, and a bladder/cystectomy subscale. The initial draft was administered to patients with bladder cancer undergoing RC and UD at two major cancer centers. Statistical methods included principal components analysis, Cronbach’s coefficient alpha, and nonparametric correlation coefficients. The FACT-G was used to test criterion-related validity and a linear mixed model tested the effects of time and diversion type on longitudinal scores. The bladder/cystectomy subscale produced a reliable and valid summary score for bladder cancer patients undergoing RC and UD. MEASURE NAME: Functional Assessment of Cancer Therapy – Bladder – Cystectomy (FACT-Bl-Cys) VERSION: 4 NUMBER OF ITEMS: 44 PATIENT POPULATION: Bladder cancer patients 18 years and older undergoing radical cystectomy and urinary diversion RECALL PERIOD: Past 7 days RESPONSE SCALE: 5 point Likert-type scale DATA COLLECTION: Paper and electronic ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Bladder/Cystectomy Subscale TIME FOR COMPLETION: 10-15 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-Bl , FBlSI , NCCN/FACT FBlSI-18 DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-Bl-Cys can be obtained by registering for permission. Users are not permitted to translate the FACT-Bl-Cys without permission from FACIT.org. Permission from FACIT.org to translate the FACT-Bl-Cys may also be contingent upon timeline expectations and availability of FACIT staff. Translations must undergo a rigorous methodology under the guidance of FACIT.org which includes multiple translators, QA steps and cognitive interviews with patients. For commercial use, FACITtrans is the approved translation vendor to translate the FACIT measurement system. Please contact us for more information. VIEW AVAILABLE LANGUAGES Language Availability Licensing Licensing Licensing fees are assessed on a per trial/per measure basis for commercial use. There is no fee for use of the English version, but a license should be obtained. Non-commercial use is assessed on a case-by-case basis. Licensing fees are typically not applied to investigator-initiated research, students, or clinical use. To license an available version of this measure for commercial or non-commercial use, please complete our registration form . All of the information provided in the form will be kept strictly confidential. For questions, please contact us . LICENSE THIS MEASURE Selected References Selected References Anderson C.B., Feurer I.D., Large M.C., Steinberg G. D., Barocas D.A., Cookson M.S., Penson D.F. Pychometric characteristics of a condition-specific health-related quality-of-life survey: The FACT-Vanderbilt Cystectomy Index. Urology; 80(1): 77-83. Bonomi, A.E., Cella, D.D., Hahn, E.A., Bjordal, K., Sperner, B., Gangeri, L., Bergman, B., Willems, J., Hanquet, P., & Zittoun, R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Quality of Life Research 1996; 5: 309-320. Eremenco, S., Arnold, B., Cella, D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions 2005; 28(2): 212-232. Webster K., Cella D., Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: Properties applications, and interpretation. Health and Quality of Life Outcomes 2003; 1(1): 79-85. Yost K.J., Eton D.T. Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Evaluation & the Health Professions 2005; 28(2): 172-191. LICENSE THIS MEASURE Related Measures Related Measures FACT-Bl Functional Assessment of Cancer Therapy – Bladder LEARN MORE FBlSI Functional Assessment of Cancer Therapy Bladder Cancer Symptom Index - 7 Item Version LEARN MORE NCCN-FACT FBlSI-18 NCCN/FACT Bladder Symptom Index LEARN MORE

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FACITtrans Expertise ACADEMICALLY TRAINED, SCIENTIFICALLY RIGOROUS FACITtrans is much more than a translation company. We are an experienced health outcomes group trained in rigorous scientific principles, grounded in robust quality control systems, ISO 9001:2015 certified, and committed to low administrative burden for our clients and vendors. Small, but mighty, industry powerhouse We have translated and linguistically validated over 100 FACIT measures into over 80 universal language versions, focusing on a wide range of disease areas such as cancer, HIV/AIDS, multiple sclerosis, and general chronic illness. We have translated hundreds of non-FACIT measures into even more languages than those present in the FACIT Measurement System. Principal translation resource for NIH initiatives In addition to our work with the pharmaceutical industry, we serve as the principal resource for translating the item banks in each of the following National Institutes of Health projects (among others): PROMIS (Patient Reported Outcomes Measurement Information System) ​ (U01 AR 052177) NeuroQOL ​ (HHSN 2652004236) NIH Toolbox (AG-260-06-01) We look forward to serving your study needs. Contact us to get started! ​ In 25+ years of providing PRO translations, we have cognitively debriefed more than 10,000 patients internationally. A voice for patients worldwide, for over 25 years Integrated expertise Our translations are grounded in state-of-the-art outcomes measurement science. Because our roots are deep in COA assessments, the translations thereof are not just a business but part of a contiguous research program, which includes all phases of COA development, assessment, measurement and clinical trial consultation. Services Quality in and across projects, no rework. LEARN MORE Label Claims Our translations in label claims. LEARN MORE Publications ​ Active contributors in the fields of translation and COAs. LEARN MORE Affiliations ​ Sponsor and contributor for 25+ years, ISOQOL, ISPOR, ATA, and more. LEARN MORE FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.