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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

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FANLTC Functional Assessment of Non-Life Threatening Conditions ​ LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Non-Life Threatening Conditions (FANLTC) is a 26-item version of the FACT-G designed to be administered to patients with non-life threatening conditions. The item from the FACT-G making reference to anxiety about death has been removed, and the instrument measures four domains of HRQOL: Physical, social/family, emotional and functional well-being. MEASURE NAME: Functional Assessment of Non-Life Threatening Conditions (FANLTC) VERSION: 4 NUMBER OF ITEMS: 26 PATIENT POPULATION: 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 TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores available. SAS/SPSS algorithms available. RELATED MEASURES: FACT-G , FACT-G7 , FACT-GP DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FANLTC can be obtained by registering for permission. Users are not permitted to translate the FANLTC without permission from FACIT.org. Permission from FACIT.org to translate the FANLTC 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.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., BarnicleM., 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. Brucker P.S., Yost K.J., Cashy J., Webster K., Cella D. General population and cancer patient norms for the Functional Assessment of Cancer Therapy – General (FACT-G). Evaluation & the Health Professions 2005; 28(2): 192-211. 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., Zagari M.J., Vandoros C., Gagnon D.D., Hurtz H.J., Nortier J.W.R. Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. Journal of Clinical Oncology 2003; 21(2): 366-373. 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-G Functional Assessment of Cancer Therapy - General LEARN MORE FACT-G7 Functional Assessment of Cancer Therapy – General – 7 Item Version LEARN MORE FACT-GP Functional Assessment of Cancer Therapy – General Population LEARN MORE

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Copyright / Terms of Use Copyright The Functional Assessment of Chronic Illness Therapy System of Quality of Life questionnaires and all related subscales, translations, and adaptations (“FACIT System”) are owned and copyrighted by David Cella, Ph.D. The ownership and copyright of the FACIT System resides strictly with Dr. Cella. Dr. Cella has granted FACIT.org (We/Us) the right to license usage of the FACIT System to other parties. Terms of Use For purposes of reviewing and learning about the FACIT measurement system, users may access and download English versions of FACIT measures and items from this website. You may also request access to translated versions by registering on the site and requesting them. However, in order to use any of our measures, permission must first be obtained by registering and obtaining a license. You can research our measures here : Once you have determined which questionnaire is best for your research question or population, you will need to register in order to either request translated versions and/or request a license-for-use. Answers to other questions can be found in our FAQ section. ​ Use of any FACIT measure without licensed permission constitutes a violation of copyright law. ​ The following terms are applicable to all our licenses. Other terms also apply: ​ If you receive a translation at no cost (e.g., if you represent a non-profit organization or hospital), you may not earn or enable any financial gain through the distribution, re-use, marketing, or transfer of the licensed material. You agree that the use or implementation of the FACIT system (including any resulting data) under your license will not be used in any commercial activity and will not benefit any party via any financial transaction. You may not modify any part of the FACIT System without expressed permission from FACIT.org. You may not translate any part of the FACIT System without expressed permission from FACIT.org. In any publication that references the FACIT System and on every element of the FACIT System used in data collection, any copyright information will be listed as it appears on the questionnaire itself. If the FACIT System is made available on the Internet, one of the following security measures must be implemented to ensure controlled access: (1) password-protected access: all users must be required to enter a valid, individualized password; (2) restricted link or access code: alternatively, access to the FACIT System may be granted through a special link or access code, which must be securely distributed and controlled by Licensee. We ask that you provide us with copies of any publications resulting from your study or produced as a result of collecting data with any FACIT questionnaire. Due to the ongoing and evolving nature of questionnaire development, treatment modalities, and cross-cultural linguistic research, FACIT.org reserves the right to make adaptations or revisions to wording in the FACIT System. If such changes occur while your license is in force, you will have the option to use the changed or unchanged version. FACIT.org reserves the right to withdraw any license if the licensee engages in scientific or copyright misuse of the FACIT system of questionnaires.