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FACT-An Functional Assessment of Cancer Therapy – Anemia For patients with Anemia/Fatigue LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy – Anemia (FACT-An) contains 20 items related to symptoms and concerns of patients with anemia along with the 27-item Functional Assessment of Cancer Therapy-General (FACT-G). Thirteen of the 20 items deal with fatigue, while the remaining 7 cover other concerns related to anemia. Using semi-structured interviews with 14 anemic oncology patients and 5 oncology experts, two instruments were produced: The FACIT-Fatigue and the FACT-Anemia. These measures were then tested with a second sample of 50 cancer patients with hemoglobin levels ranging from 7 to 15.9 g/dL. The 47-item FAC7-An scores were found to be stable (test-retest r = 0.87) and internally consistent (coefficient alpha range= 0. 95-0. 96). The symptom-specific subscales also showed good stability (test-retest r range = 0.84-0.90), and the Fatigue subscale showed strong internal consistency (coefficient alpha range = 0. 93-0. 95). Internal consistency of the miscellaneous non-fatigue items was lower but acceptable (alpha range = 0.5 9-0. 70), particularly in light of their strong relationship to patient-rated performance status and hemoglobin level. Convergent and discriminant validity testing revealed a significant positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and a predicted lack of relationship with social desirability. The FACT-An is useful measure of quality of life in cancer treatment, adding more focus to the problems of fatigue and anemia. MEASURE NAME: Functional Assessment of Cancer Therapy – Anemia (FACT-An) VERSION: 4 NUMBER OF ITEMS: 47 PATIENT POPULATION: Cancer patients 18 years and older with anemia 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, Anemia 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: FACIT-Fatigue , FACIT-F , PROMIS SF v1.0 – Fatigue 13a DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-An can be obtained by registering for permission. Users are not permitted to translate the FACT-An without permission from FACIT.org. Permission from FACIT.org to translate the FACT-An 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 Casadevall, N., Durieux, P., Dubois, S., Hemery, F., Lepage, E., Quarré, M., Damaj, G., Giraudier, S., Guerci, A., Laurent, G., Dombret, H., Chomienne, C., Ribrag, V., Stamatoullas, A., Marie, J., Vekhoff, A., Maloisel, F., Navarro, R., Dreyfus, F., & Fenaux, P. Health, economic, and quality-of-life effects of erythropoietin and granulocyte colony-stimulating factor for the treatment of myelodysplastic syndromes: a randomized, controlled trial. Blood 2004; 104(2): 321-327. doi: 10.1182/blood-2003-07-2252. Greenberg, P., Sun, Z., Miller, K., Bennett, J., Tallman, M., Dewald, G., van der Jagt, R., Houston, J., Thomas, M., Cella, D., & Rowe, J. Treatment of myelodysplastic syndromes patients with erythropoietin with or without granulocyte colony-stimulating factor: results of a prospective randomized phase III trial by the Eastern Cooperative Oncology Group (E1996). Blood 2009; 114(12): 2393–2400. doi: 10.1182/blood-2009-03-211797. Mesa, R., Niblack, J., Wadleigh, M., Verstovsek, S., Camoriano, J., Barnes, S., Tan, A., Atherton, P., Sloan, J., Tefferi, A. The Burden of Fatigue and Quality of Life in Myeloproliferative Disorders (MPDs). An International Internet-Based Survey of 1179 MPD Patients. Cancer 2007; 109(1): 68-76. doi: 10.1002/cncr.22365. Pinchon, D., Stanworth, S., Dore ´e, C., Brunskill, S., & Norfolk, D. Quality of life and use of red cell transfusion in patients with myelodysplastic syndromes. A systematic review. American Journal of Hematology 2009; 84(10):671-677. doi: 10.1002/ajh.21503. Spiriti. M., Latagliata, R., Niscola, P., Cortelezzi. A., Francesconi. M., Ferrari, D., Volpe, E., Clavio, M., Grossi. A., Reyes, M., Musto, P., Mitra, M., Azzarà, A., Pagnini, D., D’Arena, G., Spadano, A., Balleari, E., Pecorari, P., Capochiani, E., De Biasi, E., Perego, D., Monarca, B., Pisani, F., Scaramella, G., & Petti, M. Impact of a new dosing regimen of epoetin alfa on quality of life and anemia in patients with low-risk myelodysplastic syndrome. Ann Hematol 2005; 84: 167–176. doi: 10.1007/s00277-004-0961-9. Steensma, D., Heptinstall, K., Johnson, V., Novotny, P., Sloan, J., Camoriano, J., Niblack, J., Bennett, J., & Mesa, R. Common troublesome symptoms and their impact on quality of life in patients with myelodysplastic syndromes (MDS): Results of a large internet-based survey. Leukemia Research 2008; 32: 691-698. doi: 10.1016/j.leukres.2007.10.015. Trudeau, J.J., He, J., Rose, E. et al. Content validity of patient-reported outcomes for use in lower-risk myelodysplastic syndromes. J Patient Rep Outcomes 4, 69 (2020). doi.org/10.1186/s41687-020-00235-4. Yellen, S.B., Cella, D.F., Webster, K.A., Blendowski, C., & Kaplan, E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) Measurement System. Journal of Pain and Symptom Management 1997; 13(2): 63-74. 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-Fatigue Functional Assessment of Chronic Illness Therapy – Fatigue Scale LEARN MORE FACIT-F Functional Assessment of Chronic Illness Therapy – Fatigue LEARN MORE PROMIS SF v1.0 – Fatigue 13a Patient-Reported Outcomes Measurement Information System Short Form - Fatigue 13a LEARN MORE

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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Scoring OF THE FACIT MEASURES For all FACIT measures, higher scores are better than lower scores. This is true whether measuring a symptom or a functional ability. All FACIT measures use raw total scoring approach without subsequent transformation. Scoring recommendations permit for a variety of component and composite calculations, depending on the desired outcome assessment, meeting FDA guidance recommendations for both global and targeted symptom evaluation. For any FACIT measure, subscale scores are calculated by first reversing negatively stated-items (subtracting the response from ‘4’) and then summing the raw (0-4) scores. A total score is then derived by summing subscale scores. For example, a total FACT-G score is obtained by summing individual subscale scores PWB + EWB + SWB + FWB. Total scores for the disease-, treatment-, and condition-specific subscales are typically obtained by summing all subscale scores PWB + EWB + SWB + FWB + additional concerns subscale. The scoring templates provided for each measure simplify this process by providing a framework to reverse score relevant items and prorate for missing data. TOI The TOI can be computed for any FACIT disease-, treatment-, or condition-specific scale. It is the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and additional concerns subscales. Our experience with this TOI endpoint is that it is an efficient summary index of physical/functional outcomes. It is therefore a common endpoint used in clinical trials, because it is responsive to change in physical/functional outcomes, sometimes more than a total (overall) multidimensional aggregated score, which includes social and emotional well-being. While social and emotional well-being are very important to quality of life, they are not as likely to change as quickly or dramatically over time or in response to physical health interventions such as pharmaceutical treatments in clinical trials. Missing Data Relevant scoring options are outlined on each measure’s scoring template, where calculating reverse scored items and prorating for missing data has been integrated. In cases where individual items are skipped, subscale scores can be prorated using the average of the other answers in the scale. This is acceptable as long as more than 50% of the items were answered in the subscale (e.g., a minimum of 4 of 7 items, 4 of 6 items, etc.). The total score is then calculated as the sum of the un-weighted subscale scores. A FACIT measure is considered to be an acceptable indicator of patient quality of life as long as overall item response rate is greater than 80% (e.g., at least 22 of 27 FACT-G items completed). This is not to be confused with individual subscale item response rate, which allows a subscale score to be prorated for missing items if greater than 50% of items are answered. In addition, a total score should only be calculated if ALL of the component subscales have valid scores. Scoring is intended to be completed by research and clinical staff rather than patients themselves. Raw scoring templates are available in English and electronic scoring options are currently not available from FACIT.

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View all available languages for this measure. BACK FACT-M Languages Albanian Afrikaans Arabic Bulgarian Chinese – Simplified Chinese – Traditional Czech Danish Dutch English Estonian Finnish French Georgian German Greek Hebrew Hungarian Italian Japanese Korean Latvian Lithuanian Malay Norwegian Polish Portuguese Romanian Russian Sepedi Serbian Sesotho Setswana Slovak Slovene Spanish Swedish Thai Turkish Ukrainian Vietnamese Xhosa Zulu