Administration OF THE FACIT MEASURES Ideally, FACIT measures are self-administered. The original FACIT measure administration was via paper format, and most of the early measures were validated in the context of self-report via paper forms. Interviewer administration (in-person and by telephone) has also been used with success when conducted by someone trained in non-biasing interview techniques. More recently, advances in technology have enabled electronic methods for PRO administration, including by telephone using interactive voice response (IVR), and via touchscreen, computer tablet and smartphones using web-based platforms that enable electronic data collection and storage. Research comparing mode of administration for health outcome measures (paper and pencil vs computer-based assessments), including FACIT measures, has demonstrated a high degree of equivalence across a variety of patient populations and clinical settings. Interview administration is appropriate with adequate training of interviewers to minimize bias to patient responses. Across these modes of administration, our data suggest that these alternate formats are essentially equivalent. For self-administration, patients should be instructed to read the brief directions at the top of the page. After the patient's correct understanding has been confirmed, he/she should be encouraged to complete every item in order without skipping any. Some patients may feel that a given question is not applicable to them and will therefore skip the item altogether. However, patients should be encouraged to circle the response that is most applicable. If, for example, a patient is not currently receiving any treatment, the patient should circle “not at all” to the question “I am bothered by side effects of treatment.” Respondent burden is typically minimal given that the questionnaires are written at the 4th grade reading level and are specifically formatted for ease of self-administration. Average time to completion is 5-10 minutes, and even less for some stand-alone scales and symptom indices. The option to complete the questionnaire by interview also decreases burden for patients whose condition (e.g. fatigue; poor eyesight) or mood preclude them from completing the questionnaire by self-administration. We recommend that patients who complete the questionnaire by interview (in person and over the telephone) have a copy of the questionnaire or the response scale as a reference. This can help facilitate response selection in patients who have difficulty recalling the rating scale, and reduce the amount of time needed to repeat rating scale options for each individual item. We encourage the following sequence of modes, in order: Self-administration without assistance Self-administration with assistance from an objective person (i.e., not a friend or family member, but a staff person) Self-administration with assistance from a familiar person Proxy report from a familiar person Skipping items versus making them mandatory This is more of an ethical and practical issue than it is a measurement one. Ethically, patients have a right to refuse any aspect of trial participation, from taking the medicine to going to the laboratory and completing assessments. Therefore, we allow patients to decline any given question, because doing so encourages them to complete the measure rather than quit and refuse to continue. Electronic administration of the FACIT measures occurs regularly and no further usability or validity testing should be necessary. However, FACIT does not provide the electronic platform for administration and scoring of our measures. A guidance for electronic presentation of FACIT items can be found here .

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Guidance for Migration of FACIT Measures from Paper to Electronic Platforms This guidance provides instruction and information related to the migration of FACIT measures to any electronic clinical outcome assessment (eCOA) platform. This guidance will be subject to continual review and revision as electronic assessment methods evolve. Font/Layout FACIT items are presented on paper using Times New Roman 12-point font. We suggest that electronic administration aim to be as close to this standard as possible. If a 12-point font is not possible given screen size, the largest reasonable size is recommended. Use of bolded or underlined text from the paper version should be replicated in the e-version. For multiple-item layouts, it is recommended to retain as much of the formatting of the horizontal alignment of items and response options (0-4) in the paper version as possible. A vertical presentation of the response options is acceptable for single-item layouts. Title screen/copyright FACIT.org requires that the title of the measure, version number, and copyright information be listed at least once for each administered assessment. At minimum, an introductory screen should be presented prior to the measure or items with this information; where feasible, please ensure the FACIT copyright is listed on each screen. All copyright information can be found in the header and footer of the paper version of each measure. Instructions/placement FACIT paper-and-pencil measures typically contain two sentences of instructions: “Below is a list of statements that other people with your illness have said are important” and “Please select one number per line to indicate your response as it applies to the past 7 days.” Web-based implementation and/or implementation on larger devices with more than one item per screen must model the placement and wording of the instructions as they appear in the paper-and-pencil version to the extent possible. The first screen should have both instruction sentences and subsequent screens should have only the second sentence of instructions. For implementation on handheld devices, FACIT instructions should appear on a screen preceding the items. While our research suggests that the wording of the instructions is acceptable for electronic administration, we have developed alternative wording for electronic administration in which "circle or mark" has been revised to "select" which can be utilized upon request. Further revisions to the instructions to accommodate eCOA vendor device limitations are acceptable; however, FACIT.org assumes no liability for managing eCOA vendor-specific instructions nor for errors in additionally revised instructions or errors in data collection caused by revisions of instructions by eCOA vendors and their subcontractors. Items per screen For handheld devices, we recommend the display of 1 item per screen, including response options (0-4) and descriptors (not at all, a little bit, somewhat, quite a bit, very much). It is permitted to exclude response options provided the descriptors are included if the developer’s format restricts the use of numbers, but diligence must be paid in assuring proper scoring of the measure. The display of multiple items per screen is recommended with larger device screen formats. For web-based implementation and larger devices such as tablets, developers are encouraged to retain as much of the original paper format as possible. For all devices, scroll bars are not allowed. No FACIT item, including translations, should be revised without permission from FACIT.org. Response option format For web-based implementation and/or implementation on larger devices with more than one item per screen, it is encouraged to replicate the format of the paper-and-pencil version as much as possible. As noted previously, for multiple-item formats, a horizontal alignment of items and response options (0-4) is recommended with the descriptors (not at all, a little bit, somewhat, quite a bit, very much) listed above the response options (0-4). For handheld device implementation with item responses placed in a vertical format, it is recommended to display the response options next to each item, from 0 (not at all) to 4 (very much). Under no circumstances may the order of the response options be changed. No FACIT response option, including translations, should be revised without permission from FACIT.org. Subscale headers We recommend including subscale headers when a full scale/subscale is administered, but it is not required, particularly if it inhibits display of the items themselves. No FACIT subscale header, including translations, should be revised without permission from FACIT.org. Q1/GS7/Skip patterns The skip pattern with an introductory question, such as that with item GS7, should remain consistent with the paper-and-pencil version of the measure. If this is not possible due to eCOA vendor platform limitations, revisions of skip patterns are acceptable; however, FACIT.org assumes no liability for errors in additionally revised skip patterns or errors in data collection caused by revisions of skip patterns by eCOA vendors and their subcontractors. Item skipping Users should be allowed to skip items, though not invited to skip items. Users should be able to revisit items or change responses as desired prior to submitting the completed measure. Item codes, found in the shaded box that runs along the left margin of the FACIT paper forms, should ideally be presented with the item. If they are not, a minimum requirement is that they “travel” with their respective item in the software and into the database. This is essential for proper scoring and communication. Translations All FACIT measures are developed with a universal approach: for languages spoken in more than one country, there is one, universal version of a measure’s translation, rather than country-specific versions. Any changes to a translated FACIT item without written permission from FACIT.org is in violation of Intellectual Property protections and it is possible that the data analysis could be adversely affected. Screen Reviews and Certifications FACIT does not require screen review and approval of its measures. No additional certifications for electronic versions are needed. Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task Force (O’Donohoe, et. al. DOI:https://doi.org/10.1016/j.jval.2023.01.001 ) Learn about FACTtrans’ expertise with eCOA’s Version 2 | 14 May 2021

FACT-G7 Functional Assessment of Cancer Therapy – General – 7 Item Version Can be used with patients of any tumor type LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy – General – 7 Item Version (FACT-G7) is a shortened, 7-item version of the FACT-G designed to quickly and effectively capture the most relevant issues to cancer patients in a valid and reliable manner. Development included oncology patients with advanced cancer from 11 disease sites who ranked the symptoms and concerns they viewed as ‘the very most important’ when undergoing cancer treatment and completed the FACT-G. Of the highest priority cancer-related symptoms and concerns endorsed by patients for inclusion in the FACT-G7, fatigue and ability to enjoy life were ranked the most highly. The FACT-G7 can be used to rapidly assess top-rated symptoms and concerns for a broad spectrum of advanced cancers in clinical practice and research, as well as for quality reporting in cancer chemotherapy and radiation. MEASURE NAME: Functional Assessment of Cancer Therapy – General – 7 Item Version (FACT-G7) VERSION: 4 NUMBER OF ITEMS: 7 PATIENT POPULATION: 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, Emotional Well-Being, Functional Well-Being TIME FOR COMPLETION: less than 5 minutes SCORING: Manual scoring template, some items are reverse scored. Total scores possible. RELATED MEASURES: FACT-G , FACT-GP , FANLTC DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-G7 can be obtained by registering for permission. Users are not permitted to translate the FACT-G7 without permission from FACIT.org. Permission from FACIT.org to translate the FACT-G7 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 King, M., Agar, M., Currow, D., Hardy, J., Fazekas, B., & McCaffre, N. Assessing quality of life in palliative care settings: head-to-head comparison of four patient-reported outcome measures (EORTC QLQ-C15-PAL, FACT-Pal, FACT-Pal-14, FACT-G7). Supportive Care in Cancer 2020; 28:141–153. doi: 10.1007/s00520-019-04754-9. Yanez B., Pearman T., Lis C.G., Beaumont J.L., Cella D. The FACT-G7: A rapid version of the Functional Assessment of Cancer Therapy – General (FACT-G) for monitoring symptoms and concerns in oncology practice and research. Annals of Oncology 2013; 24: 1073-1078. doi:10.1093/annonc/mds539. 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. Pearman,T., Yanez B., Peipert, J., Wortman K., Beaumont J., & Cella D. Ambulatory cancer and US general population reference values and cutoff scores for the Functional Assessment of Cancer Therapy. Cancer 2014: 2902-2909. doi: 10.1002/cncr.28758. 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-G Functional Assessment of Cancer Therapy - General LEARN MORE FACT-GP Functional Assessment of Cancer Therapy - General Population LEARN MORE FANLTC Functional Assessment of Non-Life Threatening Conditions LEARN MORE