Search Results

FACT-Hep Functional Assessment of Cancer Therapy – Hepatobiliary For patients with Hepatobiliary cancer (liver, bile duct and pancreas) LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy–Hepatobiliary (FACT-Hep) is a 45-item self-report instrument designed to measure health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the 27-item FACT-G, which assesses generic HRQL concerns, and a validated 18-item Hepatobiliary Subscale (HS), which assesses disease-specific issues. Its development followed a four-phase process of item generation, item reduction, scale construction, and reliability/validity testing. Two independent samples were studied: item generation (sample 1; n = 30) and reliability/validity testing (sample 2; n = 51). All subscales and aggregated scores show high internal consistency at initial assessment (Cronbach’s alpha range, 0.72 to 0.94) and retesting (Cronbach’s alpha range, 0.81 to 0.94). Measurement stability over a 3- to 7-day period is also high for all aggregated scales (test-retest correlation range, 0.84 to 0.91; intraclass correlation coefficient range, 0.82 to 0.90). Convergent and divergent validity were demonstrated by examining relationships between FACT subscales and mood, social support, and social desirability. MEASURE NAME: Functional Assessment of Cancer Therapy – Hepatobiliary (FACT-Hep) VERSION: 4 NUMBER OF ITEMS: 45 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: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Hepatobiliary Cancer 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: FHSI , NFHSI-18 , FACT-Ga DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-Hep can be obtained by registering for permission. Users are not permitted to translate the FACT-Hep without permission from FACIT.org. Permission from FACIT.org to translate the FACT-Hep 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 Heffernan, N., Cella, D., Webster, K., Odom, L., Matone, M., Passik, S., Bookbinder, M., Fong, Y., Jarnagin, W., & Blumgart, L. Measuring health-related quality of life in patients with Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy – Hepatobiliary (FACT-Hep) questionnaire. Journal of Clinical Oncology 2002; 20(9): 2229-2239. doi: 10.1200/JCO.2002.07.093. Salem, R., Gilbertsen, M., Butt, Z., Memon, K., Vouche, M., Rickey, R., Bakers, T., Abecassis, M., Atassi, R., Riaz, A., Cella, D., Burns, J., Larson, A., Benson, A., Mulcahy, M., Kulik, L., & Lewandowski, R. Prospective quality-of-life study in hepatocellular carcinoma patients treated with chemoembolization or radioembolization. Clinical Gastroenterology and Hepatology 2013; 11(10): 1358-1365. doi: 10.1016/j.cgh.2013.04.028. Steel, J., Nadeau, K., Olek, M., & Carr, B. Preliminary results of an individually tailored psychosocial intervention for patients with advanced hepatobiliary carcinoma. Journal of Psychosocial Oncology 2007; 25(3): 19-42. doi: 10.1300/J077v25n03_02. Steel, J., Eton, D., Cella, D., Olek, M., & Carr, B. Clinically meaningful changes in health-related quality of life in patients diagnosed with hepatobiliary carcinoma. Annals of Oncology 2006; 17: 304-312. doi:10.1093/annonc/mdj072. 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 FHSI Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index - 8 Item Version LEARN MORE NFHSI-18 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index - 18 Item Version LEARN MORE FACT-Ga Functional Assessment of Cancer Therapy – Gastric LEARN MORE

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

NFBlSI-18 NCCN/FACT Bladder Symptom Index For patients with Bladder cancer; A FACT/NCCN-Bladder Symptom Index LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The NCCN-FACT Bladder Symptom Index-18 (NFBlSI-18) assesses the symptoms perceived as most important by bladder cancer patients and oncology clinical experts. A total of 31 individuals with advanced bladder cancer rated the importance of 28 symptoms. In addition, 10 oncology clinical experts rated symptoms as treatment- or disease-related. Patient-rated symptoms were reconciled with published clinicians’ symptom priorities, producing the NFBlSI-18. Participants completed measure and performance status to examine initial validity. Reliability revealed good internal consistency for the NFBlSI-18 (α = 0.83) and the measure The was significantly associated with QOL criteria and performance status in the expected direction. It is a valid, brief measure of the most important symptoms of advanced bladder cancer. MEASURE NAME: NCCN/FACT Bladder Symptom Index (NCCN/FACT FBlSI-18) VERSION: 2 NUMBER OF ITEMS: 18 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-administration and interview when applicable SUBSCALE DOMAINS: Disease-Related Symptoms – Physical, Disease-Related Symptoms – Emotional, Treatment Side-Effects, Function/Well-Being TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FBlSI , FACT-Bl , FACT-Bl-Cys DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the NFBlSI-18 can be obtained by registering for permission. Users are not permitted to translate the NFBlSI-18 without permission from FACIT.org. Permission from FACIT.org to translate the NFBlSI-18 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. Jensen S.E., Beaumont J.L., Jacobsen P.B., Abernathy A., Syrjala K., Cella D. Measuring priority symptoms in advanced bladder cancer: development and initial validation of a brief symptom index. Journal of Supportive Oncology 2013; 11(2): 86-93. 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. Degboe A., Ivanescu C., Rohay J.M., Turner R.R., Cella D. Validity and performance of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) among advanced urothelial cancer patients. Supportive Care in Cancer 2019. 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 FBlSI Functional Assessment of Cancer Therapy Bladder Cancer Symptom Index - 7 Item Version LEARN MORE FACT-Bl Functional Assessment of Cancer Therapy – Bladder LEARN MORE FACT-Bl-Cys Functional Assessment of Cancer Therapy – Bladder – Cystectomy LEARN MORE

BACK FACIT-Dyspnea Languages Arabic Afrikaans Bengali Bulgarian Chinese - Simplified Chinese - Traditional Croatian Czech Danish Dutch English Finnish French Georgian German Greek Gujarati Hebrew Hindi Hungarian Italian Japanese Kannada Korean Latvian Lithuanian Malay Malayalam Marathi Norwegian Polish Portuguese Punjabi Romanian Russian Serbian Sesotho Slovak Slovene Spanish Swahili Swedish Tagalog Tamil Telugu Thai Turkish Ukrainian Urdu Vietnamese Xhosa Zulu

NFPSI-17 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index - 17 Item Version For patients with Prostate cancer; a FACT/NCCN-Prostate Symptom Index LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The NCCN/FACT Prostate Symptom Index-17 is a brief measure that can be used to examine the effectiveness of noncurative treatments in advanced prostate cancer in line with regulatory guidance covering the spectrum of symptoms, side effects, and concerns in clinically advanced prostate cancer. Input from two waves of expert medical providers (n=66 and 11) and two waves of patient engagement and testing (n=50 and 24) resulted in a 17-item symptom index for advanced prostate cancer divided into categories based on whether the symptoms were predominantly disease or treatment related. Reliability estimates suggested good internal consistency (a=0.86) and relationships with expected outside validity criteria. This brief measure can help clinicians and researchers quickly target and measure important symptoms and concerns in advanced prostate cancer. MEASURE NAME: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index - 17 Item Version (NFPSI-17) VERSION: 2 NUMBER OF ITEMS: 17 PATIENT POPULATION: Prostate 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: Disease-Related Symptoms – Physical, Disease-Related Symptoms – Emotional, Treatment Side-Effects, Function/Well-Being TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-P , FPSI , FACT-RNT DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the NFPSI-17 can be obtained by registering for permission. Users are not permitted to translate the NFPSI-17 without permission from FACIT.org. Permission from FACIT.org to translate the NFPSI-17 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 Beaumont, J., Butt, Z., Li, R., & Cella, D. Meaningful Differences and Validity for the NCCN/FACT-P Symptom Index: An analysis of the ALSYMPCA data. Cancer 2019; 125(11): 1877-1885. doi: 10.1002/cncr.31973. 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. Rosenbloom, S., Yount, S., Yost, K., Hampton, D., Paul, D., Abernethy, A., Jacobsen, P., Syrjala, K., Von Roenn, J., & Cella, D. Development and validation of eleven symptom indices to evaluate response to chemotherapy for advanced cancer: Measurement compliance with regulatory demands. Farquhar, I., Summers, K., Sorkin, A. (Eds.). The Value of Innovation: Impacts on Health, Life Quality and Regulatory Research. Emerald Group Publishing Inc. 2007; 16: 53-66. doi: 10.1016/S0194-3960(08)16003-6. Satapathy, S., Mittal, B., Sood, A. et al. 177Lu-PSMA-617 versus docetaxel in chemotherapy-naïve metastatic castration-resistant prostate cancer: a randomized, controlled, phase 2 non-inferiority trial. Eur J Nucl Med Mol Imaging (2021). https://doi.org/10.1007/s00259-021-05618-3. Satapathy S, Mittal BR, Sood A, Das CK, Singh SK, Mavuduru RS, et al. Health-related quality-of-life outcomes with actinium-225-prostatespecific membrane antigen-617 therapy in patients with heavily pretreated metastatic castration-resistant prostate cancer. Indian J Nucl Med 2020;35:299-304. Victorson, D., Beaumont, J., Rosenbloom, S., Shevrin, D., & Cella, D. Efficient assessment of the most important symptoms in advanced prostate cancer: The NCCN/FACT-P symptom index. Psycho-Oncology 2011; 20(9): 977-983. doi: 10.1002/pon.1817. 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-P Functional Assessment of Cancer Therapy – Prostate LEARN MORE FPSI Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index - 7 Item Version LEARN MORE FACT-RNT Functional Assessment of Cancer Therapy – Radionuclide Therapy LEARN MORE

NFBSI-16 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Breast Cancer Symptom Index - 16 Item Version For patients with Breast cancer; a FACT/NCCN-Breast Symptom Index LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The NCCN/FACT Breast Cancer Symptom Index-16 contains cancer–related symptoms and concerns endorsed as high priority by both oncology patients and clinicians. Input on the most important symptoms to monitor during treatment for stage III or IV breast cancer was obtained from 52 patients recruited from National Comprehensive Cancer Network institutions as well as support service organizations. Participating patients shared their top-priority symptoms/concerns through open-ended interviews and symptom checklists. To ensure adequate content coverage, results were evaluated alongside the original version of the FBSI, which was created on the basis of a survey of oncology clinicians at National Comprehensive Cancer Network institutions and items in the FACIT measurement system. In put was also obtained from 10 National Comprehensive Cancer Network oncologists regarding whether symptoms were primarily related to disease or treatment. Results provided support for the NFBSI-16’s internal consistency reliability (α = 0.87) and validity as evidenced by moderate-to strong relationships with expected criteria. MEASURE NAME: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Breast Cancer Symptom Index - 16 Item Version (NFBSI-16) VERSION: 2 NUMBER OF ITEMS: 16 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: Disease-Related Symptoms – Physical, Disease-Related Symptoms – Emotional, Treatment Side-Effects, Function/Well-Being TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-B , FBSI , FACT-G DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the NFBSI-16 can be obtained by registering for permission. Users are not permitted to translate the NFBSI-16 without permission from FACIT.org. Permission from FACIT.org to translate the NFBSI-16 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. Clarke, N., Wong, B., Lawrance, R. et al. Validity, reliability, responsiveness, and clinically meaningful change threshold estimates of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16). J Patient Rep Outcomes 8, 97 (2024). https://doi.org/10.1186/s41687-024-00776-y Garcia, S., Rosenbloom, S., Beaumont, J., Merkel, D., Von Roenn, J., Rao, D., & Cella, D. Priority Symptoms in Advanced Breast Cancer: Development and Initial Validation of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16). Value in Health 2012; 15(1): 183-190. doi: 10.1016/j.jval.2011.08.1739. Rosenbloom, S., Yount, S., Yost, K., Hampton, D., Paul, D., Abernethy, A., Jacobsen, P., Syrjala, K., Von Roenn, J., Cella, D. Development and validation of eleven symptom indices to evaluate response to chemotherapy for advanced cancer: Measurement compliance with regulatory demands. Farquhar, I., Summers, K., Sorkin, A. (Eds.). The Value of Innovation: Impacts on Health, Life Quality and Regulatory Research. Emerald Group Publishing Inc. 2007; 16: 53-66. doi: 10.1016/S0194-3960(08)16003-6. 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-B Functional Assessment of Cancer Therapy – Breast LEARN MORE FBSI FACT Breast Symptom Index LEARN MORE FACT-G Functional Assessment of Cancer Therapy – General LEARN MORE

NFLymSI-18 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 Item Version For patients with Lymphoma (NHL); a FACT/NCCN-Lymphoma Symptom Index LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Lymphoma Symptom Index-18 (FLymSI-18) is a shortened, targeted measure for patients with lymphoma. Patients with advanced Lym (n = 50) rated the significance of 40 symptoms, and hematologist–oncologists (n = 10) rated these symptoms according to importance and disease-related or treatment-related origin. Patient symptom priorities were unified with clinician priorities for symptom measurement in lymphoma. Reliability estimates indicate that the FLymSI-18 has acceptable internal consistency (α = 0.87), content validity and concurrent validity as indicated by moderate to strong correlations with the FACIT (Functional Assessment of Chronic Illness Therapy). Overall, the FLymSI-18 provides evidence for its reliability and validity as a brief assessment of the most important symptoms associated with advanced lymphoma in clinical trials research. MEASURE NAME: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 Item Version (NFLymSI-18) VERSION: 2 NUMBER OF ITEMS: 18 PATIENT POPULATION: Lymphoma 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: Disease-Related Symptoms – Physical, Disease-Related Symptoms – Emotional, Treatment Side Effects, Function/Well-Being TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-Lym , FACT-Leu , FACT-G DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the NFLymSI-18 can be obtained by registering for permission. Users are not permitted to translate the NFLymSI-18 without permission from FACIT.org. Permission from FACIT.org to translate the NFLymSI-18 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. Hlubocky, F., Webster, K., Beaumont, J., Cashy, J., Paul, D., Abernethy, A., Syrjala, K., Von Roenn, J., & Cella, D. A preliminary study of a health related quality of life assessment of priority symptoms in advanced lymphoma: the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Lymphoma Symptom Index. Leukemia & Lymphoma 2013; 54(9): 1942-1946. doi: 10.3109/10428194.2012.762977. Rosenbloom, S., Yount, S., Yost, K., Hampton, D., Paul, D., Abernethy, A., Jacobsen, P., Syrjala, K., Von Roenn, J., & Cella, D. Development and validation of eleven symptom indices to evaluate response to chemotherapy for advanced cancer: Measurement compliance with regulatory demands. Farquhar, I., Summers, K., Sorkin, A. (Eds.). The Value of Innovation: Impacts on Health, Life Quality and Regulatory Research. Emerald Group Publishing Inc. 2007; 16: 53-66. doi: 10.1016/S0194-3960(08)16003-6. 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-Lym Functional Assessment of Cancer Therapy – Lymphoma LEARN MORE FACT-Leu Functional Assessment of Cancer Therapy – Leukemia LEARN MORE FACT-G Functional Assessment of Cancer Therapy – General LEARN MORE

NFOSI-18 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index - 18 Item Version For patients with Ovarian cancer; a FACT/NCCN-Ovarian Symptom Index LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview NCCNFACT Ovarian Index-18 (NFOSI-18) is an ovarian cancer-specific symptom index comprised of symptoms rated as highest priority by both oncology clinical experts and women with advanced ovarian cancer. Fifty-one women with advanced ovarian cancer rated the importance of 30 symptoms associated with advanced ovarian cancer. Ten gynecologic oncologists then rated symptoms according to whether they were predominantly disease- or treatment-related. Patient priorities were then reconciled with previously published clinician priorities for symptom measurement in ovarian cancer. Lower NFOSI-18 scores indicate greater high-priority symptom burden. Preliminary reliability suggests good internal consistency (α=0.80). The NFOSI-18 and its subscales were significantly positively associated with quality of life validity criteria and scores on the NFOSI-18 differed significantly by performance status, with poor performance status associated with lower NFOSI-18 scores. MEASURE NAME: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index - 18 Item Version (NFOSI-18) VERSION: 2 NUMBER OF ITEMS: 18 PATIENT POPULATION: Ovarian 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: Disease-Related Symptoms – Physical, Disease-Related Symptoms – Emotional, Treatment Side Effects, Function/Well-Being TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-O , FOSI , FACT-G DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the NFOSI-18 can be obtained by registering for permission. Users are not permitted to translate the NFOSI-18 without permission from FACIT.org. Permission from FACIT.org to translate the NFOSI-18 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. Jensen, S., Rosenbloom, S., Beaumont, J., Abernethy, A., Jacobsen, P., Syrjala, K., & Cella, D. A new index of priority symptoms in advanced ovarian cancer. Gynecologic Oncology 2011; 120(2): 214-219. doi: 10.1016/j.ygyno.2010.09.025. Rosenbloom, S., Yount, S., Yost, K., Hampton, D., Paul, D., Abernethy, A., Jacobsen, P., Syrjala, K., Von Roenn, J., & Cella, D. Development and validation of eleven symptom indices to evaluate response to chemotherapy for advanced cancer: Measurement compliance with regulatory demands. Farquhar, I., Summers, K., Sorkin, A. (Eds.). The Value of Innovation: Impacts on Health, Life Quality and Regulatory Research. Emerald Group Publishing Inc. 2007; 16: 53-66. doi: 10.1016/S0194-3960(08)16003-6. Shaunfield, s., Jensen, s., Fisher, A., Webster, K., Shahabi, S., Ganguli, A., & Cella, D. Further content validation of the 18-item NCCN/FACT Ovarian Symptom Index and its Disease Related Symptom-Physical (DRS-P) subscale for use in advanced ovarian cancer clinical trials. Health and Quality of Life Outcomes 2019; 17: 185. doi: 10.1186/s12955-019-1253-3. 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-O Functional Assessment of Cancer Therapy – Ovarian LEARN MORE FOSI Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index - 8 Item Version LEARN MORE FACT-G Functional Assessment of Cancer Therapy – General LEARN MORE

FACT-Leu Functional Assessment of Cancer Therapy – Leukemia For patients with Leukemia LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) The FACT-Leu is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. Its development consisted of two phases: scale construction and scale validation. For the item-generation phase, a summary of the literature combined with qualitative results from item-generation interviews with 29 acute or chronic leukemia patients and 16 health care providers yielded an initial item pool reflecting leukemia-specific concerns and symptoms. Items underwent iterations of review and reduction according to defined retention criteria to support content validity, as defined by priority concerns of patients. Seventeen final leukemia-specific items were combined with the Functional Assessment of Cancer Therapy–General to create the FACT-Leukemia (FACT- Leu). For the validation phase, 79 individuals with acute or chronic leukemia completed measures at three time points. Leu subscale and aggregated scores showed high internal consistency (ranging from 0.75 to 0.96).Test-retest reliability was adequate for all subscales (intraclass correlation range 0.765–0.890).It demonstrated good convergent validity, with significant correlations with quality-of-life criteria and performance status, in the expected direction. FACT-Leu subscale scores were significantly different among the three performance status change groups, suggesting good responsiveness to change. MEASURE NAME: Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) VERSION: 4 NUMBER OF ITEMS: 44 PATIENT POPULATION: Leukemia 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, Leukemia 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: FACT-Lym , NFLymSI-18 , FACT-G DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-Leu can be obtained by registering for permission. Users are not permitted to translate the FACT-Leu without permission from FACIT.org. Permission from FACIT.org to translate the FACT-Leu 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., Jensen, S., Webster, K., Du, H., Lai, JS., Rosen, S., Tallman, M., & Yount, S. Measuring health-related quality of life in leukemia: the functional assessment of cancer therapy – leukemia (FACT-Leu) Questionnaire. Value in Health 2012; 15(8): 1051-1058. doi: 10.1016/j.jval.2012.08.2210. Cella, D., Jensen, S., Webster, K., Du, H., Lai, JS., Rosen, S., Tallman, M., & Yount, S. Measuring health-related quality of life in leukemia: the functional assessment of cancer therapy – leukemia (FACT-Leu) Questionnaire. Value in Health 2012; 15(8): 1051-1058. doi: 10.1016/j.jval.2012.08.2210. Efficace, F., Cardoni, A., Cottone, F., Vignetti, M. & Mandelli, F. Tyrosine-kinase inhibitors and patient-reported outcomes in chronic myeloid leukemia: A systematic review. Leukemia Research 2013; 37(2): 206-213. doi: 10.1016/j.leukres.2012.10.021. Hamilton BK, Pandya BJ, Ivanescu C, Elsouda D, Hamadani M, Chen YB, Levis MJ, Ueda Oshima M, Litzow MR, Soiffer RJ, Ustun C, Perl AE, Singh AK, Geller N, Hasabou N, Rosales M, Cella D, Corredoira L, Pestana C, Horowitz MM, Logan B. Health-related quality of life with gilteritinib vs placebo posttransplant for FLT3-ITD+ acute myeloid leukemia. Blood Adv. 2024 Oct 8;8(19):5091-5099. doi: 10.1182/bloodadvances.2024013746. PMID: 39167766. Trask, P., Cella, D., Besson, N., Kelly, V., Masszi, T., Kim, D. Health-relate d quality of life of Bosutinib (SKI-606) in Imatinib-resistant or Imatinib-intolerant chronic phase chronic myeloid leukemia. Leukemia Research 2012; 36(4): 438-442. doi: 10.1016/j.leukres.2011.10.011. Trask, P., Cella, D., Powell, C., Reisman, A., Whiteley, J., & Kelly, V. Health-related quality of life in chronic myeloid leukemia. Leukemia Research 2013; 37(1): 9-13. doi: 10.1016/j.leukres.2012.09.013. Whiteley, J., Reisman, A., Shapiro, M., Cortes, J., & Cella, D. Health-related quality of life during bosutinib (SKI-606) therapy in patients with advanced chronic myeloid leukemia after imatinib failure. Current Medical Research & Opinion 2016; 32(8): 1325-1334. doi: 10.1185/03007995.2016.1174108. 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-Lym Functional Assessment of Cancer Therapy – Lymphoma LEARN MORE NFLymSI-18 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 Item Version LEARN MORE FACT-G Functional Assessment of Cancer Therapy – General LEARN MORE

FKSI-15 Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 15 Item Version For patients with Kidney Cancer, a 15 item scale LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The FKSI-15 is a brief symptom index for assessing quality of life for advanced kidney cancer patients comprised of items from the FACIT Measurement System. It is composed of 15 items, nine of which assess disease-related symptoms specific to kidney cancer and six of which relate to other cancer patient concerns. MEASURE NAME: Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 15 Item Version (FKSI-15) VERSION: 4 NUMBER OF ITEMS: 15 PATIENT POPULATION: Kidney 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: Kidney cancer symptom index TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Total scores possible. SAS/SPSS algorithms available. RELATED MEASURES: NFKSI-19 , FKSI-DRS , FKSI-10 DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FKSI-15 can be obtained by registering for permission. Users are not permitted to translate the FKSI-15 without permission from FACIT.org. Permission from FACIT.org to translate the FKSI-15 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 Bukowski, R., Cella, D., Gondek, K., Escudier, B. Effects of sorafenib on symptoms and quality of life results from a large randomized placebo-controlled study in renal cancer. American Journal of Clinical Oncology; 2007: 30(3): 220-227. doi: 10.1097/01.coc.0000258732.80710.05. Butt, Z., Peipert, D., Webster, K., Chen, C., & Cella, D. General population norms for the functional assessment of cancer therapy – kidney symptom index (FKSI). Cancer 2013; 119(2): 429-437. doi: 10.1002/cncr.27688. 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., Yount, S., Brucker, P., Du, H., Bukowski, R., Vogelzang, N., Bro, W. Development and validation of a scale to measure disease-related symptoms of kidney cancer. Value in Health 2007; 10(4): 285-293. doi: 10.1111/j.1524-4733.2007.00183.x. 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. Cella, D., Escudier, B., Rini, B., Chen, C., Bhattacharyya, H., Tarzai, J., Rosbrook, B., Kim, S., & Motzer, R. Patient-reported outcomes for axitinib v sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial. British Journal of Cancer 2013; 108(8): 1571–1578. doi: 10.1038/bjc.2013. Luo, X., Cappelleri, J., Cella, D., Li, J., Charbonneau, C., Kim, S., Chen, I., & Motzer, R. Using the Rasch model to validate and enhance the interpretation of the functional assessment of cancer therapy-kidney symptom index-disease related symptoms scale. Value in Health 2009; 12(4): 580-586. doi: 10.1111/j.1524-4733.2008.00473.x. Motzer, R. , Hutson, T., Olsen, M., Hudes, G., Burke, J., Edenfield, W., Wilding, Agarwal, N., Thompson, J., Cella, D., Bello, A., Korytowksy, B., Yuan, J., Valota, O., Martell, B., Hariharan, S., & Figlin, R. Randomized phase II trial of sunitinib on an intermittent versus continuous dosing schedule as first-line therapy for advanced renal cell carcinoma. Journal of Clinical Oncology 2012; 30(12): 1371-1377. doi: 10.1200/JCO.2011.36.4133. Rini, B., Wilding, G., Hudes, G., Stadler, W., Kim, S., Tarazi, J., Rosbrook, B., Trask, P., Wood, L., & Dutcher, J. Phase II Study of Axitinib in Sorafenib-Refractory Metastatic Renal Cell Carcinoma. Journal of Clinical Oncology 2009; 27(27): 4462-4468. doi: 10.1200/JCO.2008.21.7034. 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 NFKSI-19 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 19 Item Version LEARN MORE FKSI-DRS Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms LEARN MORE FKSI-10 Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 10 Item Version LEARN MORE

NFKSI-19 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 19 Item Version For patients with Kidney cancer; a FACT/NCCN Symptom Index LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The NCCN/FKSI-19 (NFKSI-19) is a brief, clinically relevant symptom index for assessing symptomatic response to chemotherapy for advanced kidney cancer. Items were extracted from a multidimensional cancer quality of life measurement system, the Functional Assessment of Cancer Therapy (FACT). Surveys of disease-related symptoms were presented to expert physicians and nurses at 17 National Comprehensive Cancer Network (NCCN) member institutions. In a two-step procedure, each expert narrowed the list to no more than five of the very most important to attend to when assessing the value of drug treatment for advanced disease. Symptoms endorsed at a frequency greater than chance probability were retained. The resulting NFKSI-19 is comprised of items relating to fatigue, pain, nausea, weight loss, worry about worsening condition, and contentment with current QOL, and were consistently selected by experts as priority symptoms. MEASURE NAME: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 19 Item Version (NFKSI-19) VERSION: 2 NUMBER OF ITEMS: 19 PATIENT POPULATION: Kidney 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: Disease-Related Symptoms – Physical, Disease-Related Symptoms – Emotional, Treatment Side-Effects, Function/Well-Being TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores available. RELATED MEASURES: FKSI , FKSI-DRS , FKSI-10 DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the NFKSI-19 can be obtained by registering for permission. Users are not permitted to translate the NFKSI-19 without permission from FACIT.org. Permission from FACIT.org to translate the NFKSI-19 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. Rao, D., Butt, Z., Rosenbloom, S., Robinson, D., von Roenn, J., Kuzel, T., & Cella, D. A comparison of the renal cell carcinoma symptom index (RCC-SI) and the Functional Assessment of Cancer Therapy – kidney symptom index (FKSI). Journal of Pain and Symptom Management 2009; 38(2): 291-298. doi: 10.1016/j.jpainsymman.2008.08.013. Rosenbloom, S., Yount, S., Yost, K., Hampton, D., Paul, D., Abernethy, A., Jacobsen, P., Syrjala, K., Von Roenn, J., & Cella, D. Development and validation of eleven symptom indices to evaluate response to chemotherapy for advanced cancer: Measurement compliance with regulatory demands. Farquhar, I., Summers, K., Sorkin, A. (Eds.). The Value of Innovation: Impacts on Health, Life Quality and Regulatory Research. Emerald Group Publishing Inc. 2007; 16: 53-66. doi: 10.1016/S0194-3960(08)16003-6. Rothrock, N., Jensen, S., Beaumont, J., Abernethy, A., Jacobsen, P., Syrjala, K., & Cella, D. Development and Initial Validation of the NCCN/FACT Symptom Index for Kidney Cancer. Value in Health 2013; 16(5): 789-796. doi: 10.1016/j.jval.2013.04.015. 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 FKSI Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 15 Item Version LEARN MORE FKSI-DRS Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms LEARN MORE FKSI-10 Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 10 Item Version LEARN MORE

FACT-RNT Functional Assessment of Cancer Therapy – Radionuclide Therapy For patients receiving radionuclide therapy LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy – Radionuclide Therapy (FACT-RNT) is a standardized measure to monitor relevant symptoms and toxicities among prostate cancer patients in RNT trials and clinical settings. It was developed first by identifying relevant symptoms and toxicities by reviewing published trials and interviewing prostate cancer patients receiving radionuclide therapy (n=529), caregivers (n=514), and clinicians (n=511), then by selecting items for inclusion. The item list was refined with input from experts in RNTs and patient reported outcomes measures. MEASURE NAME: Functional Assessment of Cancer Therapy – Radionuclide Therapy (FACT-RNT) VERSION: 1 NUMBER OF ITEMS: 15 PATIENT POPULATION: Patients receiving radionuclide therapy (RNT) for prostate cancer aged 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: RNT TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, total score possible. RELATED MEASURES: FACT-P , NFPSI-17 , FPSI DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-RNT can be obtained by registering for permission. Users are not permitted to translate the FACT-RNT without permission from FACIT.org. Permission from FACIT.org to translate the FACT-RNT 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 Gudenkauf LM, Chavez M, Maconi ML, Geiss C, Seyedroudbari A, Thin P, Hoogland AI, Nguyen K, Murthy V, Armstrong WR, Komrokji K, Oswald LB, Jim HSL, El-Haddad G, Fendler WP, Herrmann K, Cella D, Czernin J, Hofman MS, Dicker AP, Calais J, Tagawa ST, Gonzalez BD. Developing a novel patient reported outcomes measure for prostate cancer patients receiving radionuclide therapy. J Nucl Med. 2023 Jan 12:jnumed.122.264946. doi: 10.2967/jnumed.122.264946. Epub ahead of print. PMID: 36635088. LICENSE THIS MEASURE Related Measures Related Measures FACT-P Functional Assessment of Cancer Therapy – Prostate LEARN MORE NFPSI-17 NCCN/FACT Prostate Cancer Symptom Index - 17 Item Version LEARN MORE FPSI FACT Prostate Cancer Symptom Index - 7 Item Version LEARN MORE