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FPSI Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index - 7 Item Version For patients with Prostate cancer; A FACT-Prostate Symptom Index (a subset of FACT-P containing 7 items) LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details for the FPSI measure: MEASURE NAME: Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index - 7 Item Version (FPSI) VERSION: 4 NUMBER OF ITEMS: 7 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: Prostate cancer symptom index 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-P , NFPSI-17 , FACT-RNT DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FPSI can be obtained by registering for permission. Users are not permitted to translate the FPSI without permission from FACIT.org. Permission from FACIT.org to translate the FPSI 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. 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-P Functional Assessment of Cancer Therapy – Prostate LEARN MORE NFPSI-17 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index - 17 Item Version LEARN MORE FACT-RNT Functional Assessment of Cancer Therapy – Radionuclide Therapy LEARN MORE

Additional Measures LICENSED BY FACIT.ORG SMDDS : Symptoms of Major Depressive Disorder Scale MFSAF v4.0 : Myelofibrosis Symptom Assessment Form v4.0 Diary MFSAF v4.0 : Myelofibrosis Symptom Assessment Form v4.0 7-day Recall NSCLC-SAQ: Non-Sm all Cell Lung Cancer Symptom Assessment Questionnaire ADSD/ANSD: Asthma Daytime Symptom Diary and Asthma Nighttime Symptom Diary DIBSS-C: Diary for Irritable Bowel Syndrome Symptoms - Constipation All C-Path Clinical Outcome Assessment (COA) Measures C-Path COA measures and their licensing procedures can be found on the C-Path COA website. Clicking the link below will leave the FACIT site and redirect you to the C-Path COA website. Go to the C-Path COA website OMWQ : Oral Mucositis Weekly Questionnaire OMDQ : Oral Mucositis Daily Questionnaire HAMSIQ : Hand-Foot and Mucositic Symptom and Impact Questionnaire MICRA : Multidimensional Impact of Cancer Risk Assessment PRAI : Patient-Reported Arthralgia Inventor y PRRS: Patient Roles and Responsibilities Scale CRRS: Caregiver Roles and Responsibilities Scale PROMIS SF v1.0 - Fatigue 10a : Patient-Reported Outcomes Measurement Information System - Fatigue Short Form 10a PROMIS SF v1.0 – Fatigue 13a : Patient-Reported Outcomes Measurement Information System - Fatigue Short Form 13a PROMIS SF v1.0 – Dyspnea-Severity 10a : Patient-Reported Outcomes Measurement Information System - Dyspnea Severity Short Form 10a PROMIS SF v1.0 – Dyspnea Functional Limitations 10a : Patient-Reported Outcomes Measurement Information System - Dyspnea Functional Limitations Short Form 10a PROMIS SF v1.0 – Dyspnea-Severity 5a : Patient-Reported Outcomes Measurement Information System - Dyspnea Severity Short Form 5a PROMIS SF v1.0 – Dyspnea-Severity 5b : Patient-Reported Outcomes Measurement Information System - Dyspnea Severity Short Form 5b PROMIS SF v1.0 – Dyspnea-Functional Limitations 5a : Patient-Reported Outcomes Measurement Information System - Dyspnea Functional Limitations Short Form 5a PROMIS SF v1.0 – Dyspnea-Functional Limitations 5b : Patient-Reported Outcomes Measurement Information System - Dyspnea Functional Limitations Short Form 5b PROMIS Item Bank v1.0 – Dyspnea Severity : Patient-Reported Outcomes Measurement Information System Item Bank - Dyspnea Severity PROMIS Item Bank v1.0 – Dyspnea Functional Limitations : Patient-Reported Outcomes Measurement Information System Item Bank - Dyspnea Functional Limitations BESS : BCPT Eight Symptom Scale NVMBQ: Nausea and Vomiting Management Barriers Questionnaire DMD: Diarrhea Management Diary Deep Vein Thrombosis Leg Symptom Index (DVT-LSI) LICENSE A MEASURE COA information updated frequently.

FACIT Measures & Languages SUB-TITLE PLACEHOLDER CELEBRATING 15 YEARS as a boutique language service provider FACITtrans is pleased to announce our 15-year business anniversary as a boutique language service provider of clinical outcome assessment (COA) translation, linguistic validation and other translation services to the life science industry. Since our group’s inception in academia over 25 years ago, we have continued to develop and advance our expertise in rigorous measurement and linguistic methodologies on behalf of health outcomes researchers and pharma clients internationally. Our Team Responsive interdisciplinary expertise grounded in academic science. Meet the FACITtrans TEAM Our History Over 25 years of methodologically rigorous COA translations. FACITtrans HISTORY

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FLSI-12 Functional Assessment of Cancer Therapy Lung Cancer Symptom Index - 12 Item Version For patients with Lung cancer; a FACT-Lung Symptom Index (a subset of FACT-L containing 12 items) LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details for the FLSI-12 measure: MEASURE NAME: Functional Assessment of Cancer Therapy Lung Cancer Symptom Index - 12 Item Version (FLSI-12) VERSION: 4 NUMBER OF ITEMS: 12 PATIENT POPULATION: Lung 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: Lung cancer symptom index TIME FOR COMPLETION: Less than 5 minutes SCORING: Manual scoring template, some items are reverse scored. Total scores possible. RELATED MEASURES: FACT-L , FLSI , NFLSI-17 , FACT-PSI , FACT-LCS DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FLSI-12 can be obtained by registering for permission. Users are not permitted to translate the FLSI-12 without permission from FACIT.org. Permission from FACIT.org to translate the FLSI-12 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., Eton, D., Hensing, T., Masters, G., & Parasuraman, B. Relationship between symptom change, objective tumor measurements, and performance status during chemotherapy for advanced lung cancer. Clinical Lung Cancer 2008; 9(1): 51-58. doi: 10.3816/CLC.2008.n.009. Yount, S., Rothrock, N., Bass, M., Beaumont, J., Pach, D., Lad, R., Patel, J., Corona, M., Weiland, R., Del, K., & Cella, D. A randomized trial of weekly symptom telemonitoring in advanced lung cancer. Journal of Pain and Symptom Management 2014; 47(6): 973-989. doi: 10.1016/j.jpainsymman.2013.07.01. 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-L Functional Assessment of Cancer Therapy – Lung LEARN MORE FLSI Functional Assessment of Cancer Therapy Lung Cancer Symptom Index - 6 Item Version LEARN MORE NFLSI-17 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lung Cancer Symptom Index - 17 Item Version LEARN MORE

FACIT Measures & Languages SUB-TITLE PLACEHOLDER At FACIT, our passion is the patient. Our mission is providing a voice for patients worldwide. With longstanding academic ties, FACIT is an organization grounded in rigorous health outcomes measurement methods with the aim of improving global health outcomes research. Comprised of two inter-related organizations, FACIT.org and FACITtrans, our multidisciplinary teams provide clients an international pool of talent from a wide variety of academic and clinical resources. In addition to licensing the well-known FACIT system of questionnaires, FACIT.org also licenses several other measures such as the C-Path Clinical Outcomes Assessments (COA’s). Our team at FACITtrans provides translation services of unsurpassed quality to the international clinical research community. Since 1994, the team at FACITtrans has served as a pioneer in the translation and linguistic validation of COA’s and other international clinical trial documents, serving on several Special Interest Groups (SIG’s) and contributing to the body of science and literature of cross-cultural health assessment. Our Vision As part of a cutting edge health outcomes research program, the application of our knowledge and resources serve the patient's interests. We make a difference in patients’ lives by ensuring their perspective of their disease or treatment is measured and conveyed in a culturally, semantically and linguistically appropriate manner. Our services contribute to improved quality of life for patients and aid clinicians in solving complex healthcare challenges, thus providing value to our clients and contributing to their growth. We fulfill this vision by fostering collaborations based on state of the art science, respect, integrity and compassion with our colleagues in academia and the pharmaceutical industry. Our international staff of devoted project managers, linguists and clinicians take each of these challenges to heart. Our Values In a position of service to patients, researchers and clinicians, we hold the following tenets as integral to our success: Quality systems underpinning all processes to ensure our translations say what they mean, and mean what they say. Adherence to the highest scientific principles. Integrity and ethical conduct in all business and interpersonal transactions. Respect and appreciation for our colleagues, clients, vendors and patients. Fostering of long term relationships based on respect, trust and understanding of mutual needs. Fiscal responsibility. Our Team Responsive interdisciplinary expertise grounded in academic science. FACIT.org TEAM FACITtrans TEAM Our History Over 25 years of improving patient health status measurement and methodologically rigorous COA translations. FACIT.org HISTORY FACITtrans HISTORY

Professional Society Membership & Affiliations We at FACITtrans view professional memberships as an integral part of sharing knowledge within our many communities. We are a proud member and active contributor to the following leading professional organizations: ISOQOL: International Society for Quality of Life Research Member for more than 20 years, and a proud financial sponsor. Our Executive Director, Benjamin Arnold, served as ISOQOL’s Translation and Cross-Cultural Adaptation - Special Interest Group (TCA-SIG) Co-Chair from 2016 to 2018, is currently a member of the TCA-SIG Steering Committee and the Ibero America SIG. Our Director of Translations, Emily Parks-Vernizzi, served as ISOQOL’s TCA-SIG Co-Chair from 2021 to 2023 and is currently a member of the TCA-SIG Steering Committee and the Digital Health and eCOA SIG (https://www.isoqol.org/sigs/ ) ​ We regularly attend ISOQOL Annual Conferences and meetings in North America, Europe, Asia and Latin America where we consistently present posters, presentations, and workshops related to translation and cultural adaptation of Clinical Outcome Assessment (COA) measures. ISPOR: International Society for Pharmacoeconomics and Outcomes Research ​ Member for more than 20 years, and we are active participants in the Chicago Regional Chapter (CRC). Founding member of the ISPOR Task Force for Translation and Cultural Adaptation, which established “Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO)” (Wild, 2005). A number of our team members are building the ISPOR Clinical Outcomes Assessment Task Force with other recognized professionals in the field. We regularly present posters, present at panel discussions and attend ISPOR’s Annual Conferences and meetings in North America, Europe, Asia and Latin America. ATA: American Translators Association ​ Member for more than 20 years Our team regularly presents at conferences, publishes articles, presents posters, and attends meetings. PHO: PROMIS Health Organization (PHO) and Health Measures Conferences ​ We proudly support the PHO, whose mission is to improve health outcomes by developing, maintaining, improving, and encouraging the application of the Patient Reported Outcomes Measurement Information System (PROMIS) in research and clinical practice. ​ At the PHO’s Annual conferences, we regularly present posters, presentations, and facilitate roundtable discussions related to translation and cultural adaptation of PROMIS measures. ​ We also contribute financially on a yearly basis so that the PHO can hold its Annual Conferences where scientists present and exchange PROMIS-related research information and learnings. Women's Shelter Women's Shelter: ​ Each year we gladly contribute to this organization that provides vital services and support to women in need.

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FACIT Measures & Languages OVER 100 MEASURES IN AS MANY AS 80 LANGUAGES Below is a current list of measures available to license from FACIT.org. Permission for use must be obtained by selecting 'license this measure' on any measure's page. Generally, licensing fees are waived for non-profit organizations and clinical settings. A licensing fee will be assessed if the user or any associate of the user intends to use the FACIT system for any commercial or other financially profitable purpose in the context of the relevant study or data. Clinical Outcome Assessments (COA) Translation Most outcomes measures have been developed and validated in English. In order to ensure that data collected in multinational clinical trials can be pooled for analysis and ultimately submitted for a label claim, translated versions of COA's must be as conceptually and culturally equivalent as possible. To achieve this equivalence, a rigorous translation methodology with attendant focus on quality and cultural appropriateness is imperative. Through our industry-wide recognized translation approach, we deliver on the promise that our translations are linguistically and culturally appropriate for each target population, and that patients across the globe understand translated items as intended by the English source instrument. Linguistic Validation Patients live with their disease, treatment or conditions. As such, patients themselves provide the most informative, useful perspective on a questionnaire's (COA’s) content. FACITtrans’ full COA translation methodology specifically requires interviewing patients with the translated questionnaire and asking them questions about the items in order to fully capture the target-language patient’s voice and experience. This process, called “cognitive interviewing”, helps ensure the final translated versions are as conceptually and culturally equivalent as possible. These steps seek to affirm the linguistic validity of the translated measure and ultimately strengthen our clients’ ability to understand the multinational patient perspective and obtain a label claim from internationally-collected clinical trial data. At FACITtrans, we believe capturing the patient voice is imperative. As highlighted on our History page, our team was part of the original publication of these now widely-accepted translation approaches. For over 20 years our mission has been Providing A Voice for Patients Worldwide. We deliver on this promise to patients and our clients every day. eCOA Translation, Adaptation, Migration and Screenshot Proofreading" Electronic Clinical Outcome Assessment (eCOA) is a way of capturing data electronically in clinical trials. Many measures were developed for paper administration. When adapted for electronic assessment, often there must be some adjustments to the measure’s instructions or layout. FACITtrans’ eCOA expertise includes: Adapted over 90% of FACIT scales into as many as 70 languages Adapted over 15 non-FACIT instruments into as many as 30 languages Currently supporting >15 pharma clients & eCOA vendors FACITtrans provides these services: Instruction adaptation for clear patient comprehension Adapt language to fit context of device Multilingual migration to XML, JSON and CSV formats Screenshot proofing across variety of electronic platforms Learn about FACTtrans’ expertise with eCOA’s Interview Transcription & Translation Conducting interviews in other countries, but need transcripts of the interview in English? We have years of experience transcribing interviews, and translating the interviews into English for you. Quality checks are scheduled at each step of the process. Translation of Consent forms, Diaries, Event Logs and Protocols" As longtime members of an academic research community (it's where we got our start!) we are well versed in the administrative and legal requirements of clinical trial research. Standardized documentation such as diaries, event logs, or legal/administrative documentation like consent forms or protocols require simpler translation methods but with rigorous quality and semantic monitoring. Translatability Assessment and Concept Definition COA measures are most-often developed in English, and certain concepts may not translate easily or prove to have limited or no conceptual equivalence in other cultures. Translatability Assessment refers to the proactive process of identifying such issues as early in the instrument development process as possible. Concept definition, also referred to as concept elaboration, goes hand in hand with this process and serves to define terminology and intended meaning of items providing acceptable translation alternatives, unacceptable translation alternatives, and offering solutions for specific translation issues within linguistic families. Engagement with instrument developers is crucial at these key stages to ensure the intended meaning of each item is conveyed to produce translated items that say what they mean and mean what they say.