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BACK NFBSI-16 Languages Afrikaans Arabic Bengali Bulgarian Chinese - Simplified Chinese - Traditional Czech Danish Dutch English Finnish French German Greek Hebrew Hindi Hungarian Italian Kannada Korean Malay Malayalam Marathi Polish Portuguese Punjabi Romanian Russian Spanish Swedish Tamil Telugu Vietnamese

CELEBRATING 15 YEARS as a boutique language service provider LEARN MORE Welcome to FACIT Welcome to FACIT FACITtrans provides clinical outcomes assessment (COA) translatability assessment, questionnaire, consent form and protocol translation, interview transcription and translation, eCOA adaptation and migration, linguistic validation and more. FACIT.org manages the distribution of and information related to more than 100 questionnaires that measure health-related quality of life for people with chronic illnesses. Together we are pioneers in the field of patient-centered research with 25+ years of cutting-edge science and services. A 不 Translation & Linguistic Validation Services FACIT Measurement System FACIT Searchable Library COA Management & Licensing Services NEWS We are happy to announce our publication in Quality of Life Research : Translation and linguistic validation of 24 PROMIS item banks into French Need help? Contact us.

FACT-B Functional Assessment of Cancer Therapy – Breast For patients with Breast cancer LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). Utilized with the 27 core FACT-G items, the FACT-B was developed with an emphasis on patients’ values and brevity. Initial validation involved two patient samples. The first was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample. The alpha coefficient (internal consistency) for the FACT-B total score was high (a = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. MEASURE NAME: Functional Assessment of Cancer Therapy – Breast (FACT-B) VERSION: 4 NUMBER OF ITEMS: 37 PATIENT POPULATION: Breast 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: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Breast Cancer Subscale TIME FOR COMPLETION: 10-15 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI possible. SAS/SPSS algorithms available. RELATED MEASURES: NFBSI-16 , FBSI , FACT-B+4 DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-B can be obtained by registering for permission. Users are not permitted to translate the FACT-B without permission from FACIT.org. Permission from FACIT.org to translate the FACT-B 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 Brady M.J., Cella D.F., Mo F., Bonomi A.E., Tulsky D.S., Lloyd S.R., Deasy S., Cobleigh M., Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy – Breast quality-of-life instrument. Journal of Clinical Oncology 1997; 15(3): 974-986. 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. Cella D., Land S.R., Chang C.H., Day R., Costantino J.P., Wolmark N., Ganz P.A. Symptom measurement in the Breast Cancer Prevention Trial (BCPT) (P-1): Psychometric properties of a new measure of symptoms for midlife women. Breast Cancer Research and Treatment 2008; 109: 515-526. 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. Eton D.T., Cella D., Yost K.J., Yount S.E., Peterman A.H., Neuberg D.S., Sledge G.W., Wood W.C. A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. Journal of Clinical Epidemiology 2004; 57: 898-910. Hahn, E.A., Holzner, B., Kemmler, G., Sperner-Unterweger, B., Hudgens, S., Cella, D. Cross-cultural evaluation of health status using item response theory: FACT-B comparisons between Austrian and U.S. breast cancer patients. Evaluation & the Health Professions 2005; 28(2): 233-259. Henderson V.P., Massion A.O., Druker S. The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: A randomized trial. Breast Cancer Research and Treatment 2012; 131: 99-109. Kugbey, N., Meyer-Weitz, A., & Oppong Asante, K. Access to health information, health literacy and health-related quality of life among women living with breast cancer: Depression and anxiety as mediators. Patient Education and Counseling 2019; 102(7): 1357-1363. doi: 10.1016/j.pec.2019.02.014. Kugbey, N., Meyer-Weitz, A., & Oppong Asante, K. Mental adjustment to cancer and quality of life among women living with breast cancer in Ghana. The International Journal of Psychiatry in Medicine 2019; 54(3): 217-230. doi: : 10.1177/0091217418805087. Kugbey, N., Oppong Asante, K., & Meyer-Weitz, A. Doctor–patient relationship mediates the effects of shared decision making on health-related quality of life among women living with breast cancer. South African Journal of Psychology 2019; 49(3); 364–375. doi: 10.1177/0081246318801. Kugbey, N., Oppong Asante, K., & Meyer-Weitz, A. Depression, anxiety and quality of life among women living with breast cancer in Ghana: mediating roles of social support and religiosity. Supportive Care in Cancer 2019; 1-8. doi: 10.1007/s00520-019-05027-1. Lemieux J., Goodwin P.J., Bordeleau L.J., Lauzier S., Théberge V. Quality-of-life measurement in randomized clinical trials in breast cancer: An updated systematic review (2001-2009). Journal of the National Cancer Institute 2011; 103(3): 178-231. Pandey M., Thomas B.C., Ramdas K., Eremenco S., Nair M.K. Quality of life in breast cancer patients: Validation of a FACT-B Malayalam version. Quality of Life Research 2002; 11: 87-90. Thomas R., Godward S., Makris A., Bloomfield D., Moody A.M., Williams M. Giving patients a choice improves quality of life: A multi-centre, investigator-blind, randomized, crossover study comparing Letrozole and Anastrozole. Clinical Oncology 2004; 16: 485-491. Ursini LA, Nuzzo M, Rosa C, DI Guglielmo FC, DI Tommaso M, Trignani M, Borgia M, Allajbej A, Patani F, DI Carlo C, Porreca A, DI Nicola M, Genovesi D, Caravatta L. Quality of Life in Early Breast Cancer Patients: A Prospective Observational Study Using the FACT-B Questionnaire. In Vivo. 2021 May-Jun;35(3):1821-1828. doi: 10.21873/invivo.12443. PMID: 33910868. 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 NFBSI-16 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Breast Cancer Symptom Index - 16 Item Version LEARN MORE FBSI Functional Assessment of Cancer Therapy - Breast Symptom Index LEARN MORE FACT-B+4 Functional Assessment of Cancer Therapy – Lymphedema LEARN MORE

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BACK FACT-EGFRI-18 Languages Arabic Bulgarian Cebuano Chinese - Simplified Chinese - Traditional Czech Dutch English French Georgian German Hebrew Hungarian Italian Japanese Korean Latvian Malay Polish Portuguese Romanian Russian Serbian Spanish Tagalog Tamil Thai Turkish Ukrainian Vietnamese

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FACIT.org History OVER 25 YEARS OF IMPROVING PATIENT HEALTH STATUS MEASUREMENT 1990’s 1997 Late 90’s Mid-2000’s 2018 TODAY 1980’s FACIT.org is the licensing entity for the well-known FACIT measurement system. Because of its strong development and validation processes plus its exceptional measurement characteristics, the FACIT System is widely used in clinical and academic research, as well as in clinical trials to capture the patient's perspective of their disease, treatment or condition. 1980s 1980’s The patient's perspective in focus Renowned health outcomes researcher David Cella, Ph.D., develops the Functional Assessment of Cancer Therapy (FACT) questionnaire while completing his post-doctoral studies at Memorial Sloan Cancer Center in New York. (Cella et al, 1993) The results of his work formed the cornerstone of the Functional Assessment of Chronic Illness Therapy, a compilation of over 100 distinct self-report questionnaires that assess a wide variety of symptoms, functional abilities, general perceptions of health and well-being, and other aspects of health-related quality of life. Some of these questionnaires are disease-specific (e.g., cancer, multiple sclerosis, HIV disease), some are related to specific treatment-related toxicities (e.g., central or peripheral neurotoxicity, gastrointestinal toxicity), some are symptom focused (e.g., pain, fatigue), others address physical, mental and social function, and still others assess mood and well-being. All were developed and created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages in which each item has been translated. ​ Cella D.F., Tulsky D.S., Gray G., Sarafian B., Lloyd S., Linn E., Bonomi A., Silberman M., Yellen S.B., Winicour P., Brannon J., Eckberg K., Purl S., Blendowski C., Goodman M., Barnicle M., Stewart I., McHale M., Bonomi P., Kaplan E., Taylor S., Thomas C., Harris J. The Functional Assessment of Cancer Therapy (FACT) Scale: Development and validation of the general measure. Journal of Clinical Oncology 1993; 11(3): 570-579. 1990 1997 Late 90s Mid-2000s 2018 Today 1990’s The FACT goes global As globalization evolves, the demand for valid, translated versions of the FACT measures rises. The FACT Translation Project begins, and the FACT-G (General), FACT-B (Breast), FACT-Br (Brain), FACT-BMT (Bone Marrow Transplant), FACT-C (Colorectal), FACT-CNS (Central Nervous System), FACT-Cx (Cervical), FACT-E (Esophageal), FACT-H&N (Head & Neck), FACT-L (Lung), FACT-P (Prostate), FACT-O (Ovarian), and FAHI (HIV) become the first measures translated and linguistically validated into 7 languages following a newly-developed FACIT translation methodology ensuring equivalence across translations. Today, over 100 measures are available in over 80 languages. 1997 FACT becomes FACIT Functional Assessment of Chronic Illness Therapy (FACIT) is adopted as the formal name to reflect the FACT’s growth and evolution into a system that also includes content to measure diseases, treatments and conditions outside oncology. Late 90’s Item Response Theory and FACIT Advanced methods in statistical and psychometric approaches including item response theory (IRT) provide increasingly robust analytic methods permitting analysis on a per-item basis. Use of IRT to examine an item’s measurement characteristics gives investigators a way to lower patient response burden by only administering items most relevant to patients. Mid-2000’s Dr. Cella launches PROMIS The National Institute of Health supports this science via an initiative known as PROMIS (Patient Reported Outcomes Measurement Information System), in which Dr. Cella is the Principal Investigator of the Statistical Coordinating Center. A second federally-funded item-banking project specific to neurological conditions, Neuro-QOL, follows; Dr. Cella grants permission for FACIT items to be used in both these initiatives so that these FACIT items can be scored on a national metric. Dr. Cella remains a central resource to the PROMIS Health Organization to this day. 2018 ​ FACIT Searchable Item Library In 2018, the FACIT Searchable Item Library is released. Users may now search FACIT’s 700+ items and develop a custom measure targeted to their specific patients using the Build-a-PRO function. Today Looking ahead FACIT continues to evolve with increasing focus on individual item measurement, the use of Clinical Outcomes Assessments (COA’s) in routine clinical practice and new items and measures for use with immune checkpoint modulator (ICM) treatments for chronic illness. Meet the Team David Cella, PhD President, Chief Scientific Officer Jason Bredle, MFA Director Shannon Romo Licensing and Financial Administrator MEET THE WHOLE TEAM