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FACT-Cx Functional Assessment of Cancer Therapy – Cervix For patients with cancer of the Cervix LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details for the FACT-Cx measure: MEASURE NAME: Functional Assessment of Cancer Therapy – Cervix (FACT-Cx) VERSION: 4 NUMBER OF ITEMS: 39 PATIENT POPULATION: Cervical 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, Cervical 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: FACIT-CD , FACT-V , FACT-En DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-Cx can be obtained by registering for permission. Users are not permitted to translate the FACT-Cx without permission from FACIT.org. Permission from FACIT.org to translate the FACT-Cx 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 Ashing-Giwa, K. Enhancing physical well-being and overall quality of life among underserved Latina-American cervical cancer survivors: feasibility study. Journal of Cancer Survivorship: Research and Practice 2008; 2(3):215-223. doi: 10.1007/s11764-008-0061-2. Chase, D., Huang, H., Wenzel, L., Cella, D., McQuellon, R., Long, H., Moore, D., & Monk, B. Quality of Life and survival in advanced cervical cancer: A Gynecologic Oncology Group Study. Gynecologic Oncology 2012; 125(2): 315-319. doi: 10.1016/j.ygyno.2012.01.047. Long, H., Bundy, B., Grendys, E., Benda, J., McMeekin, D., Sorosky, J., Miller, D., Eaton, L. & Fiorica, J. Randomized Phase III Trial of Cisplatin With or Without Topotecan in Carcinoma of the Uterine Cervix: A Gynecologic Oncology Group Study. Journal of Clinical Oncology 2005; 23(21): 4626-4633. doi: 10.1200/JCO.2005.10.021. Monk, B., Sill, M., McMeekin, D., Cohn, D., Ramondetta, L., Boardman, C., Benda, J., & Cella, D. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a gynecologic oncology group study. Journal of Clinical Oncology 2009; 27(28): 4649-4655. doi: 10.1200/JCO.2009.21.8909. 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-CD Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia LEARN MORE FACT-V Functional Assessment of Cancer Therapy – Vulva LEARN MORE FACT-En Functional Assessment of Cancer Therapy – Endometrial LEARN MORE

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Over 25 years of methodologically rigorous COA translations. FACITtrans History OVER 25 YEARS OF METHODOLOGICALLY RIGOROUS COA TRANSLATIONS 1994 1996 2000 2001 2004 2005 2009 2012 2017 2021 1993 1993 1993 Patient perspective on effects of cancer treatment gain recognition As part of increasing interest from the international clinical and research communities to assess the patient's perspective of his or her disease, David Cella, Ph.D. publishes the original manuscript on his development of the Functional Assessment of Cancer Therapy FACT-G. Cella D.F., Tulsky D.S., Gray G., Sarafian B., Lloyd S., Linn E., Bonomi A., Silberman M., Yellen S.B., Winicour P., Brannon J., Eckberg K., Purl S., Blendowski C., Goodman M., Barnicle M., Stewart I., McHale M., Bonomi P., Kaplan E., Taylor S., Thomas C., Harris J. The Functional Assessment of Cancer Therapy (FACT) Scale: Development and validation of the general measure. Journal of Clinical Oncology 1993; 11(3): 570-579. 1994 1994 Clinicians request the FACT-G in Spanish Careful consideration of equivalence and quality are at the forefront of this endeavor. The translation group that will become FACITtrans is born. 1996 1996 A call to quality within the PRO/HRQOL community The initial manuscript on the translation and linguistic validation of the FACT scale is published. 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. 2000 2000 The translation group’s work gains recognition The first requests to translate COAs by other developers begin. 2001 2001 The translation group publishes an article, and causes a stir Our translation group develops the first iteration of an article in support of the universal translation approach, which 20 years later is still considered methodologically novel. Advantages of the Universal Approach: Enables comparisons across subgroups, assuming the scale applied is unbiased (e.g. Spanish speaking populations in the US). Minimizes bias introduced by multiple translations in a survey or clinical trial. Reduces logistical complexity in multinational clinical trials. Facilitates survey administration in the case of migrating populations. 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. 2004 2004 Item banking translation begins Item banking translation begins with the PROMIS into Spanish. 2005 2005 Our translation group contributes to landmark ISPOR translation and cultural adaptation guidelines The result is the seminal manuscript, “Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient‐Reported Outcomes (PRO)” . Translation companies rush to adopt this methodology that is now accepted as industry standard. 2009 2009 The translation and formatting team formerly part of CORE becomes FACITtrans The transition from academia to a business environment frees our group to be even more responsive and streamlined, permitting more effective response times and quicker turnaround for the deadline-driven pharmaceutical clinical trial industry. Under the scientific direction of Dr. Cella, the outcomes scientists at MSS and the translation and formatting team of FACITtrans have world-class experience and expertise in translation and linguistic validation, outcomes research design, database development, multicenter data collection and management, psychometrics and statistics. 2012 2012 Adapt FACIT measures for electronic administration The FACIT Group starts to modify text for FACT and FACIT questionnaires’ use on tablets and other devices. 2017 2017 FACITtrans earns ISO 9001:2015 certification Quality processes have always been central to our work, which is why we co-founded the ISPOR translations guidelines so many years ago. In 2017 we went a step further to seek recognition on an international level for how we work. This resulted in a very rewarding moment when we received praise from the auditing agency and our ISO 9001:2015 certification. 2021 2021 FACITtrans earns ISO 17100:2015 certification Harnessing the energy from our ISO 9001:2015 certification, we placed our translation and linguistic validation processes under additional scrutiny to earn our ISO 17100:2015 certification, further reinforcing our high quality work. Today Today Collaboration is our strength While most of our work is for top pharmaceutical companies, we regularly partner with Dr. Cella’s research program at Northwestern University - the largest academically-based outcomes research group in the world. We also collaborate on NIH initiatives such as PROMIS, and with industry leaders like C-Path. Our President, Benjamin Arnold, and Executive Director, Emily Parks-Vernizzi, served as Co-Chairs during separate terms, and are now permanent steering committee members of ISOQOL’s Translation and Cultural Adaptation Special Interest Group (TCA-SIG). Meet the Team Benjamin Arnold, MA President Emily Parks-Vernizzi, MBA Executive Director MEET THE WHOLE TEAM FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

With over 25 years of licensing and Intellectual Property (IP) management experience, we can optimize your measure’s exposure and support its use within the HEOR and QOL scientific communities. COA Management & Licensing Services QUESTIONNAIRE LICENSING SERVICES With over 25 years of licensing and Intellectual Property (IP) management experience, we can optimize your measure’s exposure and support its use within the HEOR and QOL scientific communities. Why choose FACIT.org as your licensing partner? Simple We make it easy . All licensing and related infrastructure tasks are coordinated at one source. Flexible Flexible terms . Measurement ownership by FACIT.org or the original copyright holder. Shared licensing and distribution fees possible. Support Support you need . FACIT.org provides users all scoring, interpretation and relevant publications, and all general Q&A support for measure implementation. Service Unparalleled customer service . At FACIT.org, we are always open to measure-specific needs, questions or adaptations. We Offer... Dynamic Partnership FACIT.org can either incorporate your measure into our existing structure or develop a new measure-specific infrastructure. Measurement Promotion License and distribute English/source language versions to users at no fee. Research-centric License for academic and non-profit clinical use of any language version is provided at no fee. No Repeat Costs After an initial translation fee for pharma-sponsored trials, subsequent uses of said translation(s) are free of charge to the sponsor. A licensing fee applies to for-profit requests by companies who are not the original sponsor. Cooperation While FACIT.org charges a licensing fee to for-profit users who request translated versions, we can sometimes adapt fees if required by the IP developer. View Additional Measures We License We look forward to hearing from you to assist in supporting the licensing and distribution of your validated instrument! Contact Our Licensing Team About Managing Your Measure

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.

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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Committed to rigorous scientific measurement of the patient's perspective. FACIT.org Team COMMITTED TO RIGOROUS SCIENTIFIC MEASUREMENT OF THE PATIENT'S PERSPECTIVE Jason Bredle, MFA Director, FACIT.org BIO Shannon Romo Financial Manager BIO Sharon Debb, M.Ed Licensing Manager BIO Robert Martin, BA Licensing Support Specialist BIO Paul Cella, PhD Licensing Support Specialist BIO David Cella, PhD President, Chief Scientific Officer BIO Benjamin Arnold, MA President, FACITtrans, LLC BIO Lauren Lent, DHA, MS Founder, The FACIT Group BIO Luke Pickard, MBA Director of IT, Data Protection Officer (IT DPO) BIO Our History Over 25 years of improving patient health status measurement. LEARN MORE Our Vision, Mission, and Values At FACIT, our passion is the patient. Our mission is to provide a voice for patients worldwide. LEARN MORE

The FACIT Measurement System is a collection of over 700 items, 130 pediatric items, and 100 validated measures targeted to the management of chronic illness. FACIT Measures & Searchable Library OVERVIEW The FACIT Measurement System is a collection of over 700 items, 130 pediatric items, and 100 validated measures targeted to the management of chronic illness. "FACIT" (Functional Assessment of Chronic Illness Therapy) was adopted as the formal name of the measurement system in 1997 to portray the expansion of the "FACT" (Functional Assessment of Cancer Therapy) measures into other chronic illnesses and conditions. The measurement system, under development since 1988, is a comprehensive collection of patient reported measures that assess general health-related quality of life (HRQoL) and specific disease- and treatment-related concerns across multiple chronic illnesses and the general population. The measurement system (originally referred to as the Functional Assessment of Cancer Therapy, or FACT) emerged from a conceptual framework for quality of life in the context of health status that is centered on two essential principles: subjectivity and multidimensionality. HRQoL is uniquely personal, defined by patient experiences and influenced by one’s subjective perspective. Therefore, HRQoL is best assessed by direct-report. HRQoL is multidimensional, including, but not limited to symptoms, side effects, and functional status. It also includes more general appraisals of life quality and value. Meaningful assessment comes from asking patients about these distinct, yet often correlated areas of function and well-being. There is general consensus that key domains of HRQoL include physical, functional, emotional, and social/family well-being. Physical well-being refers to perceived and observed bodily function or disruption and includes symptoms such as pain, fatigue, and nausea. Functional well-being refers to one’s ability to perform the activities related to one’s personal needs, ambitions, or social role and includes things like ability to work, sleep, and enjoy life. Emotional well-being covers positive and negative affect as well as life enjoyment and appreciation. Social/family well-being includes a broader range of perceived support, leisure activities, family wellbeing, and intimacy. Over time, this framework has expanded to include additional targeted domains such as disease-specific symptoms and treatment side effects for more comprehensive and clinically relevant assessment Validation of the core measure allowed for the evolution of multiple disease, treatment, condition, and other targeted measures. FACIT scales are constructed to complement the FACT-G, addressing relevant disease-, treatment-, or condition-related issues not already covered in the general questionnaire. Each is intended to be as specific as necessary to capture the clinically-relevant problems associated with a given condition or symptom, yet general enough to allow for comparison across diseases, and extension, as appropriate, to other chronic medical conditions. The FACIT Measurement System now includes over 700 items, some of which have been translated into more than 80 languages. Assessment of any one patient is tailored so that the most-relevant questions are asked and administration time for any one assessment is usually less than 15 minutes. The majority of FACIT items have demonstrated face and content validity and were created with direct input from patients and expert clinicians. More recently, FACIT has expanded its catalog of items to the FACIT Searchable Library , where one can create a custom form using the site’s Build-a-PRO function and include only those FACIT items most relevant to one’s study or purpose. While doing so does not instantly validate the custom composition, it does create an opportunity to select specific items relevant to the research question at hand, using content valid items that have undergone careful translation into other languages. It also allows for the opportunity to pursue validation of the assembled set of questions using standard questionnaire validation practice. The practice of selecting an established, fixed FACIT measure is still recommended for any investigator or clinician wishing to obtain a valid, interpretable score on the endpoints provided by that FACIT measure. FACIT Measures FACIT Searchable Library Administration Scoring eCOA Guidance Interpretation Translation & Linguistic Validation Methodology Label Claims FACIT Utilities

View all available languages for this measure. BACK FACIT-GP5 Languages Afrikaans Albanian Amharic Arabic Armenian Assamese Belarusian Bengali Bosnian Bulgarian Burmese Catalan Cebuano Chinese - Simplified Chinese - Traditional Croatian Czech Danish Dutch English Estonian Farsi Finnish French Galician Georgian German Greek Gujarati Haitian Creole Hebrew Hiligaynon Hindi Hungarian Icelandic Ilokano Indonesian Italian Japanese Kannada Kazakh Korean Latvian Lithuanian Luganda Macedonian Malay Malayalam Maltese Marathi Mongolian Montenegrin Nepali Norwegian Odia Polish Portuguese Punjabi Romanian Russian Sepedi Serbian Sesotho Setswana Sinhala Slovak Slovene Spanish Swahili Swedish Tagalog Tamil Telugu Thai Turkish Ukrainian Urdu Vietnamese Welsh Wolof Xhosa Zulu

All items in the FACIT Searchable library were created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages into which each item has been translated. The FACIT Searchable Library The FACIT Measurement System is a compilation of over 100 distinct self-report questionnaires that assess a wide variety of symptoms, functional abilities, general perceptions of health and well-being, and other aspects of health-related quality of life. These measures are comprised of over 700 unique items appropriate for use with adults aged 18 and over, and more than 130 items appropriate for children ages 8-18. Most FACIT items have demonstrated face and content validity, and were created with direct input from patients and expert clinicians. Many items have also been translated into nearly 80 languages (reaching over 100 countries) using a standardized, rigorous translation methodology and tested for comprehension by native speakers. All items in the FACIT Searchable library were created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages into which each item has been translated. Until 2017, people used these items via static FACIT questionnaires in a fixed, validated format. Now, with the introduction of the FACIT Searchable Library, one can create a custom form using the site’s Build-a-PRO function and include only those FACIT items most relevant to one’s study or purpose. While doing so does not instantly “validate” the custom composition, it does create an opportunity to select specific items relevant to the research question at hand, using content valid items that have undergone careful translation into other languages. It also allows for the opportunity to pursue validation of the assembled set of questions using standard questionnaire validation practice. Two recent trends have led us to provide this new approach: One is the introduction of item response theory (IRT) into health measurement. One of the guiding principles of IRT measurement is the basic ‘fungibility’ of items measuring the same underlying concept, or domain. In an IRT-calibrated item bank, one can “pick-and choose” items from that bank, according to their content relevance in a given setting. The score obtained is generalizable to other studies or samples that may have used a different set of items from the same bank. Given this, the introduction of IRT into health measurement has led to the question of whether or not more classically-developed measurement systems such as FACIT could consider the value of customized individual item selection. Some FACIT items have become incorporated into or linked with national item banks such as PROMIS and Neuro-QoL, and these could indeed be scored on those national metrics. However, most FACIT items have not been incorporated or linked to existing IRT item banks and would therefore not be able to produce interpretable scores beyond the single item raw score, which is the starting point for most custom forms. The second trend leading to this new approach has been increasing pressure from government and private sectors, including patient advocates, to ask only those questions that are directly relevant to the hypothesis of a given study or treatment comparison. This pressure has been growing for several years, culminating in the release of the National Cancer Institute’s Patient Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE), which is a set of 124 items that query 78 symptom terms from the larger (clinician-rated) CTCAE v4.0. The FACIT Searchable Library covers all of the PRO-CTCAE major categories, maps to 55 of its 78 symptom terms, and addresses several other disease symptoms and treatment adverse events. Similar to how the PRO-CTCAE is deployed, any user could sample questions from the FACIT Searchable Library and evaluate, in descriptive fashion, how one treatment compared to another, on an item-by-item basis. Below are five easy steps to build a custom assessment from the FACIT Searchable Library: Step 1: Educate yourself on the content of the item library. Search by Symptom, Function, General Perceptions, or Other. Or search by PRO-CTCAE category for comparison. Step 2: Evaluate the fit of item content to your research goal. Think in terms of item content, relevance, readability, and language availability. Step 3: Using the ‘Build-a-PRO’ function, create a custom form in English. Register to request permission for use. Step 4: Validate your new questionnaire with data you collect as to its scalability and responsiveness. Step 5: Publish your results and cite the FACIT Searchable Item Library as your source for items. Some frequently asked questions: FAQ How do I select items? It is best to select items that have face validity with regard to the hypotheses or goals of your study. For example, if you are interested in pain, diarrhea, fatigue and nausea as disease- or treatment-related symptoms, select the questions in those symptom areas that best fit your patient population. How do I score the items I selected? Unless you use an existing, validated FACIT subscale or scale, or a set of IRT-calibrated items, do not score multi-item scales until you have conducted proper scaling analyses and validated the sum score using appropriate methods. How do I use the items? Use them for item-level comparisons across treatments, or within a treatment over time, to estimate emerging or dissipating symptoms or functional abilities. Consider proportion of cases responding over a certain pre-defined threshold as more easily interpreted than average scores of a group. Also consider adding in individual items to a validated questionnaire. How do I validate the items I selected? Validation is a process of accumulating evidence, more than an end goal. There are established methods for validating any newly-constructed scale. It is usually done by first establishing the factor structure of the item responses, and then comparing the scores on scales constructed from these factors to scores of similar questionnaires or other variables that convey similar meaning to what the summed set of questions is believe to measure (e.g., a brief fatigue scale, or a brief social function scale, etc.). The advantage of starting with the FACIT Searchable Library is the knowledge that all items were written with patient input and tested to ensure comprehension and ease of administration. Language translations were conducted with state-of-the-art methods to ensure cross-cultural relevance and semantic equivalence. Standardized static, validated FACIT questionnaires range in length from 4-60 items. The practice of selecting an established, fixed FACIT questionnaire is still recommended for any investigator or clinician wishing to obtain a valid, interpretable score on the endpoints provided by that FACIT questionnaire. But custom form development may be useful for some researchers in need of a novel, functional method for more targeted assessment. To explore the FACIT Searchable Library and its potential for custom generated forms using FACIT items, click below. By clicking below, you will be directed to the FACIT Searchable Library section of our website. You can find more specific information about the FACIT Searchable Library in the FAQ’s section. We hope you find this latest iteration of our measurement system as interesting as we do. Go To The FACIT Searchable Library