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FACT-HN Functional Assessment of Cancer Therapy – Head & Neck For patients with Head & Neck cancer LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy – Head & Neck (FACT-H&N) is a reliable and valid measure for head and neck cancer patients, assessing unique disease specific concerns in addition to general health status. FACT-H&N subscale and total scores are sensitive to patient groups on the basis of treatment status (on vs. off treatment) and global performance status. The head & neck subscale includes 12 items on symptoms and issues specific to head and neck cancers, including ability to eat, dry mouth, difficulty breathing, difficulty swallowing, voice quality, ability to communicate, body image, pain in the mouth, throat, or neck, and alcohol and tobacco use. MEASURE NAME: Functional Assessment of Cancer Therapy – Head & Neck (FACT-HN) VERSION: 4 NUMBER OF ITEMS: 39 PATIENT POPULATION: Head & neck 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, Head & Neck 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: FHNSI , NFHNSI-22 , FACT-MBIS DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-HN can be obtained by registering for permission. Users are not permitted to translate the FACT-HN without permission from FACIT.org. Permission from FACIT.org to translate the FACT-HN 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 D'Antonio, L., Zimmerman G., Cella, D., & Long, S. Quality of life and functional status measures in patients with head and neck cancer. Archives of Otolaryngology-Head & Neck Surgery 1996; 122: 482-487. List, M.A., D'Antonio, L.L., Cella, D.F., Siston, A., Mumby, P., Haraf, D., & Vokes, E. The Performance Status Scale for Head and Neck Cancer (PSS-HN) and the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) Scale: A study of utility and validity. Cancer 1996; 77(11): 2294-2301. doi: 10.1002/(SICI)1097-0142(19960601)77:11<2294::AID-CNCR17>3.0.CO;2-S. Nayak SG, George A, Sharan K, Nayak BS, Ravishankar N. Effectiveness of Comprehensive Intervention Programme on Quality of life, fatigue, self-efficacy, and psychosocial distress among head and neck cancer patients receiving radiotherapy. Support Care Cancer . 2024 Mar 7;32(4):216. doi: 10.1007/s00520-024-08381-x. PMID: 38448712; PMCID: PMC10917822. Reeve, B., Cai, J., Zhang, H., Choi, J., Weissler, M., Cella, D., & Olshan, A. Health-related quality of life differences between African-Americans and Non-Hispanic whites with head and neck cancer. Head and Neck 2013; 35(9): 1255-64. doi: 10.1002/hed.23115. Ringash J, Lockwood G, O'Sullivan B, Warde P, Bayley A, Cummings B, Kim J, Sellmann S, & Waldron J. Hyperfractionated, accelerated radiotherapy for locally advanced head and neck cancer: quality of life in a prospective phase I/II trial. Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology, 2008; 87(2):181-187. doi: 10.1016/j.radonc.2007.12.028. Ringash, J., Bernstein, L, Cella, D., Logemann, J., Movsas, B., Murphy, B., Trotti, A., Wells, N., Yueh, B., & Ridge, J. Outcomes toolbox for head and neck cancer research. Head & Neck 2015; 37(3): 425-39. doi: 10.1002/hed.23561. 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 FHNSI Functional Assessment of Cancer Therapy Head & Neck Cancer Symptom Index - 10 Item Version LEARN MORE NFHNSI-22 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Head & Neck Cancer Symptom Index - 22 Item Version LEARN MORE FACT-MBIS FACT/McGill Body Image Scale - Head & Neck LEARN MORE

BACK FACT-LCS Languages Arabic Bengali Chinese - Simplified Chinese - Traditional Croatian Czech Danish Dutch English Finnish French German Greek Gujarati Hebrew Hindi Hungarian Italian Kannada Korean Malay Malayalam Marathi Polish Portuguese Punjabi Russian Spanish Swedish Tamil Telugu Thai Ukrainian Urdu

BACK FAMS Languages Arabic Bulgarian Chinese - Traditional Croatian Czech Danish Dutch English Farsi Finnish French German Greek Hebrew Hungarian Italian Japanese Korean Norwegian Polish Portuguese Romanian Russian Serbian Slovak Spanish Swedish Turkish Ukrainian

FACT-ICM Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator For patients receiving immunotherapy treatment LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Derived from FACIT's item library for the assessment of patient-reported adverse events for immune checkpoint modulators, the FACT-ICM was developed to measure QOL in patients being treated with immunotherapy. The larger item bank can be accessed by searching "immunotherapy" within FACIT's Searchable Item Library. MEASURE NAME: Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator VERSION: 4 NUMBER OF ITEMS: 52 PATIENT POPULATION: Cancer patients 18 years and older receiving immunotherapy treatment 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, Immune Checkpoint Modulator Subscale TIME FOR COMPLETION: 10-15 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores possible. RELATED MEASURES: FACT-G , FACT-M , FACT-L DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-ICM can be obtained by registering for permission. Users are not permitted to translate the FACT-ICM without permission from FACIT.org. Permission from FACIT.org to translate the FACT-ICM 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 Hansen AR, Ala-Leppilampi K, McKillop C, Siu LL, Bedard PL, Abdul Razak AR, Spreafico A, Sridhar SS, Leighl N, Butler MO, Hogg D, Sacher A, Oza AM, Al-Agha R, Maurice C, Chan CT, Shapera S, Feld JJ, Nisenbaum R, Webster K, Cella D, Parsons J. Development of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs. Cancer. 2020 Apr 1;126(7):1550-1558. doi: 10.1002/cncr.32692. Epub 2020 Jan 8. PMID: 31914209. Webster KA, O’Connor ML, Hansen AR, Kircher S, Jim HSL, Dicker AP, Janda M, Ala-leppilampi K, Bingham CO III, Feliciano J, Henry NL, Steffen McLouth LE, Cella D. Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators. J Cancer Metastasis Treat 2020;6:8. http://dx.doi.org/10.20517/2394-4722.2019.38. 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-G Functional Assessment of Cancer Therapy – General LEARN MORE FACT-M Functional Assessment of Cancer Therapy – Melanoma LEARN MORE FACT-L Functional Assessment of Cancer Therapy – Lung LEARN MORE

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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.

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