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FAACT Functional Assessment of Anorexia/Cachexia Treatment For patients with Anorexia/Cachexia LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns. It includes the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) and a 12 item subscale that specifically measures the symptoms and concerns of patients with anorexia/cachexia (A/CS). The A/CS subscale can be used in conjunction with the FACT-G or as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). Chang et al (2003) has shown this “intensity” rating scale to be essentially equivalent to a “frequency” rating scale (i.e., “none of the time” to “all of the time”). The recall period for each question is “during the past 7 days” and this time frame has been found to provide more precise information than a 4-week time frame (Lai et al 2009). All FACIT scales are scored so that a high score is good. As each of the 12 items of the FAACT anorexia/cachexia-specific subcale ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response. All responses are added with equal weight to obtain the total score. In cases where some answers may be missing, a total score is prorated from the score of the answered items, so long as more than 50% of the items (i.e., at least 7 of 12) were answered. The FAACT was developed with input from both patients and clinicians. Semistructured interviews conducted with 10 patients and 5 practitioners generated 32 candidate anorexia/cachexia items (Cella et al 1993). The practitioners who helped generate the items were also later asked to review the entire list of items. The items underwent multiple iterative reviews to reduce redundancy and clarify wording, resulting in a final list of 18 anorexia/ cachexia items. These items were then pilot tested in 10 cancer and 6 HIV-infected patients with anorexia/cachexia. Patients were asked to rate each item in terms of importance (0, not at all important to 4, very important). All items were found to be sufficiently important for retention in the next stage. The FAACT was then validated in a randomized trial comparing 200mg vs. 800mg per day of megestrol acetate oral suspension in 213 patients with cancer (n=155) or HIV (n=58) (Ribaudo et al 2001). The majority of the cancer patients had non small cell lung cancer. The FAACT was administered by computer at baseline and at weeks 4 and 12. The Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) was administered at weeks 4 and 12 only. The anorexia/cachexia subscale was reduced from 18 to 12 items. Items were removed because they were conceptually dissimilar to eating concerns (e.g., “I have diarrhea”) or minimally correlated with the total score (e.g., “I enjoy eating breakfast”). The Cronbach’s coefficient alpha did not change significantly with removal of those items (from 0.77 for both cancer and HIV patients to 0.76 for cancer and 0.78 for HIV). The correlation between 18-item and 12-item scores was 0.94. Scores on the 12-item subscale significantly differed between groups defined by ECOG PSR and were sensitive to change in PSR. MEASURE NAME: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) VERSION: 4 NUMBER OF ITEMS: 39 PATIENT POPULATION: Cancer patients 18 years and older experiencing anorexia/cachexia 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, Anorexia/Cachexia Subscale TIME FOR COMPLETION: 10-15 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores possible. SAS/SPSS algorithms available. RELATED MEASURES: peds FAACT , FACIT-AD , FACIT-AI DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FAACT can be obtained by registering for permission. Users are not permitted to translate the FAACT without permission from FACIT.org. Permission from FACIT.org to translate the FAACT 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 Blauwhoff-Buskermolen, S., Ruijgrok, C., Ostelo, R., de Vet, H., Verheul, H., de van der Schueren, M., & Langius, J. The assessment of anorexia in patients with cancer: cut-off values for the FAACT–A/CS and the VAS for appetite. Support Care Cancer 2016; 24: 661–666. doi: 10.1007/s00520-015-2826-2. Change, V., Xia,Q, & Kasimis, B. The Functional Assessment of Anorexia/ Cachexia Therapy (FAACT) Appetite Scale in Veteran Cancer Patients. The Journal of Supportive Oncology 2005; 3(5): 377-382. Gelhorn, H., Gries, K., Speck, R., Duus, E., Bourne, R., Aggarwal, D., & Cella, D. Comprehensive validation of the functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subcale (A/CS) in lung cancer patients with involuntary weight loss. Quality of Life Research 2019; 28(6): 1641-1653. doi: 10.1007/s11136-019-02135-7. Lai, J-S., Cella, D., Peterman, A., Barocas, J., & Goldman, S. Anorexia/Cachexia related QOL for children with cancer: Testing the psychometric properties of the pediatric functional assessment of anorexia and cachexia therapy (peds-FAACT). Cancer 2005; 104(7): 1531-1539. LeBlanc, T., Samsa, G., Wolf, S., Locke, S., Cella, D., & Abernethy, A. Validation and real-world assessment of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in patients with advanced non-small cell lung cancer and the cancer anorexia-cachexia syndrome (CACS). Support Care Cancer 2015; 23: 2341–2347. doi 10.1007/s00520-015-2606-z. Ribaudo, J., Cella, D., Hahn, E., Lloyd, S., Tchekmedyian, N., Von Roenn, J., & Leslie, W. Re-validation and shortening of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Quality of Life Research 2001; 1137-1146. Salsman, J., Beaumont, J., Wortman, K., Yan, Y., Friend, J., & Cella, D. Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia. Supportive Care in Cancer 2015; 23 (5): 1355-1364. doi: 10.1007/s00520-014-2484-9. Yennurajalingam, S., Frisbee-Hume, S., Palmer, J., Delgado-Guay, M., Bull, J., Phan, A., Tannir, N., Litton, J., Reddy, A., Hui, D., Dalal, S., Massie, L., Reddy, S., & Bruera, E. Reduction of Cancer-Related Fatigue With Dexamethasone: A Double-Blind, Randomized, Placebo-Controlled Trial in Patients With Advanced Cancer. Journal of Clinical Oncology 2013; 31(25): 3076-3082doi: 10.1200/JCO.2012.44.4661. Zhou,T., Yang,K., Thapa, S., Fu, Q, Jiang, Y. , & Yu, S. Validation of the Chinese version of functional assessment of anorexia-cachexia therapy (FAACT) scale for measuring quality of life in cancer patients with cachexia. Support Care Cancer 2017; 25: 1183–1189. doi: 10.1007/s00520-016-3508-4. 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 peds FAACT Pediatric Functional Assessment of Anorexia/Cachexia Treatment LEARN MORE FACIT-AD Functional Assessment of Chronic Illness Therapy - Abdominal Discomfort LEARN MORE FACIT-AI Functional Assessment of Chronic Illness Therapy - Ascites Index LEARN MORE

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Label claims information relevant to both FACIT measures and FACITtrans' translations. Label Claims LABEL CLAIM INFORMATION RELEVANT TO BOTH FACIT MEASURES AND FACITtrans’ TRANSLATIONS What is a label claim? In the US, the Food and Drug Administration (FDA) is responsible for oversight of medicinal products; the concurrent European Union (EU) organization is called the European Medicines Agency (EMA or EMEA). The package inserts accompanying a drug list all of the medicine’s risks and benefits so that patients and their caregivers are informed of them. In the US these inserts are called “labels”; in Europe they’re called “SmPCs”. The label’s content represents the formal, legal representation of what the drug can and cannot do, including side effects and potential hazards or toxicities. The label establishes the legal boundaries of what the medicine’s developers can promote (or “claim”) about its effects. Given the huge investment pharmaceutical companies make in each drug, the stronger their label claim , the better their chances their drug will be received by clinicians and patients. How does the FDA view the use of PRO’s in label claims? In 2009 the FDA released its Guidance for Industry, Patient Reported Outcomes: Use in Medical Product Development to Support Labeling Claims (PRO guidance) https://www.fda.gov/media/77832/download providing specific directives related to how PRO data can be used in a product’s label. A central tenet of the Guidance is that the PRO measure must demonstrate that it measures the construct on which the label claim is based. For example, if the pharma sponsor is hoping for a label claim that its drug improves patient quality of life (QoL) and functionality by reducing fatigue, it must use a PRO measure which has demonstrated it is a valid and reliable measure that is sensitive to changes in fatigue. The sponsor must concurrently demonstrate a correlation between fatigue and QoL Where do Clinical-Outcome-Assessment (COA’s) fit into label claims? COA’s and Patient Reported Outcome (PRO) Measures in particular, have become widely accepted as valid tools to incorporate in clinical trials to measure the patient’s perspective of his or her disease, treatment, condition or symptom. PROs are widely used in clinical trials to help sponsors differentiate their drug from others that may clinically perform similarly to other drugs. In many cases PRO’s can provide sensitive data for conditions that are not necessarily cured (like side effects), but instead might be mitigated to the point where the patient’s quality of life (QOL) or functional ability is enriched. These can be critical parameters to patients with chronic conditions; having a label claim which states that some aspect of life quality is improved while taking that drug can boost sales significantly. From a statistical perspective, a PRO label claim can be based upon primary, secondary or (in some rare cases) exploratory study aims. Using PRO data as a primary endpoint requires that a direct link be established between the change in patient score and the disease, condition or symptom being treated. Using PRO data as a secondary study endpoint would mean that the PRO data would be used as either secondary to improvement in a clinical indication (i.e. the disease would be cured) OR to demonstrate there are other treatment benefits. An exploratory analysis is not typically used for labeling but may result in evidence or data that another study is warranted which focuses on a new finding. Per Gnanasakthy et al (2012 ) the majority of PRO label claims granted have been primary endpoints focused on symptoms. How does the EMA view the use of PRO’s in label claims? The EMA issued a reflection paper in 2005 which did not provide specific requirements, but rather was intended more as a reference document to provide some broad recommendations and context for the incorporation of Health- Related Quality of Life (HRQL) into the drug evaluation process. The FDA and EMA have differing standards for the use of PRO’s for labeling purposes. The FDA has strict recommendations requiring the validity of the construct being measured and also focuses more on clinical symptoms. The FDA also has more rigorous study design and analysis requirements. The EMA is more flexible with regard to open label studies and more amorphous patient-reported perspectives. Perhaps because of this, the EMA permitted more label claims in oncology trials from 2012-2016. During this period, according to Gnanasakthy et al ( 2019 ), 49 oncology drugs across 64 indications were approved by the EMA, however “no FDA labeling was identified.” It should be noted that the FDA’s Oncology Division has reviewed and approved PRO label claims for indications outside cancer, and other FDA divisions outside of oncology have approved PRO label claims. We note that the EMA views FACIT measures favorably in oncology trials. Gnanasakthy et al (2019) note “A Functional Assessment of Cancer Therapy (FACT) measure was included in 12 (26.6%) submissions and led to labeling for 8 (38.1%) indications. Notably, FACT measures led to a proportionately greater share of EMA PRO labeling when included in a submission (8 of 12 [66.7%]) as compared to EORTC measures (9 of 26 [34.6%]). These 2 commonly used measures with their disease-specific modules were granted PRO labeling in two-thirds of reviews (14 of 21 [66.6%]).” What measures has FACITtrans translated that were used in label claims? FACITtrans has performed all the translations and linguistic validation for any FACIT measure so we are pleased to have contributed to any of our clients’ label claims that included a FACIT questionnaire in their QOL endpoint. An overview of FACIT measures used in label claims can be found here. Confidentiality obligations do not permit us to specify which drugs used non-FACIT PRO’s translated by FACITtrans. Because we have been in this clinical trial “space” for nearly three decades, we are pleased to have contributed to many clients’ successful PRO label claims submissions. We can also state that as a preferred translation partner of the PROMIS instruments, we have collaborated in several studies’ multinational PROMIS claims submissions. The FACIT Group would like to specifically and gratefully acknowledge the contributions of Ari Gnanasakthy, M.Sc. at RTI Health Solutions and his colleagues who publish periodically on PRO’s in label claims.

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PROMIS SF v1.0-Dyspnea-Severity 10a Patient Reported Outcomes Measurement Information System - Short Form - Dyspnea-Severity 10a For patients with dyspnea LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The PROMIS SF v1.0 – Dyspnea-Severity 10a is part I of the FACIT-Dyspnea adopted by the PROMIS Health Organization. MEASURE NAME: Patient Reported Outcomes Measurement Information System - Short Form - Dyspnea-Severity 10a VERSION: 1 NUMBER OF ITEMS: 10 PATIENT POPULATION: Dyspnea patients 18 years and older RECALL PERIOD: Past 7 days RESPONSE SCALE: 4 point Likert-type scale DATA COLLECTION: Paper and electronic For permission to implement and administer the measure electronically, please visit: https://www.healthmeasures.net/implement-healthmeasures/administration-platforms ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Severity TIME FOR COMPLETION: Less than 5 minutes SCORING: PROMIS Scoring Service: http://www.healthmeasures.net/score-and-interpret/calculate-scores/scoring-instructions RELATED MEASURES: FACIT-Dyspnea , PROMIS SF v1.0 – Dyspnea-Severity 5a , PROMIS SF v1.0 – Dyspnea-Severity 5b DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the PROMIS-SF-v1.0-Dyspnea-Severity 10a can be obtained by registering for permission. Users are not permitted to translate the PROMIS-SF-v1.0-Dyspnea-Severity 10a without permission from FACIT.org. Permission from FACIT.org to translate the PROMIS-SF-v1.0-Dyspnea-Severity 10a 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 Choi, S., Victorson, D., Yount, S., Anton, S., & Cella, D. Development of a conceptual framework and calibrated item banks to measure patient reported dyspnea severity and related functional limitations. Value in Health 2011; 14: 291-306. Ruo, B., Choi, S., Baker, D., Grady, K., & Cella,D. Development and validation of a computer adaptive test measuring dyspnea in heart failure. Journal of Cardiac Failure 2010; 16(8): 659-668. doi: 10.1016/j.cardfail.2010.03.002. Victorson, D., Anton, S., Hamilton, A., Yount, S., & Cella, D. A conceptual model of the experience of dyspnea and functional limitations in COPD. Value in Health 2009; 12(6): 1018-1025. Yount, S., Choi, S., Victorson, D., Ruo, B., Ray, D., Cella, D., Anton, S., & Hamilton, A. (2011) Brief, valid measures of dyspnea and related functional limitations in chronic obstructive pulmonary disease (COPD). Value in Health 2011; 14: 307-315. 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 FACIT-Dyspnea Functional Assessment of Chronic Illness Therapy - Dyspnea-10 item LEARN MORE PROMIS SF v1.0 – Dyspnea Severity 5a Patient-Reported Outcomes Measurement Information System Short Form - Dyspnea Severity 5a LEARN MORE PROMIS SF v1.0 – Dyspnea Severity 5b Patient-Reported Outcomes Measurement Information System Short Form - Dyspnea Severity 5b LEARN MORE

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FBlSI Functional Assessment of Cancer Therapy Bladder Cancer Symptom Index - 7 Item Version For patients with Bladder cancer; a FACT-Bladder Symptom Index (a subset of FACT-Bl containing 7 items) LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details of the FBlSI: MEASURE NAME: Functional Assessment of Cancer Therapy Bladder Cancer Symptom Index - 7 Item Version (FBlSI) VERSION: 4 NUMBER OF ITEMS: 7 PATIENT POPULATION: Bladder 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-administeration and interview when applicable SUBSCALE DOMAINS: Bladder Cancer Subscale 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-Bl , FACT-Bl-Cys , NFBlSI-18 DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FBlSI can be obtained by registering for permission. Users are not permitted to translate the FBlSI without permission from FACIT.org. Permission from FACIT.org to translate the FBlSI 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. 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 FACT-Bl-Cys Functional Assessment of Cancer Therapy – Bladder – Cystectomy LEARN MORE NFBlSI-18 Functional Assessment of Cancer Therapy – Bladder – Cystectomy LEARN MORE