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FACT-GOG-NTX-12 Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 12 Item Version For patients with Neurotoxicity LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The FACT/GOG-NTX provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. This instrument has been demonstrated to be reliable and has internal consistency, content validity, and concurrent validity with sensitivity to change over time among various samples of cancer patients undergoing chemotherapy. The psychometric properties of the 13-item FACT/GOG-NTX have been established with a large sample of clinical trial participants who received an oxaliplatin-based regimen for operable colorectal cancer. The FACT/GOG-NTX subscale yields a single aggregate score, which simplifies its use as a clinical trial endpoint. Individual items can be reviewed in the clinical setting to identify clinically significant symptomatology. MEASURE NAME: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 12 Item Version (FACT/GOG-NTX-12) VERSION: 4 NUMBER OF ITEMS: 39 PATIENT POPULATION: Cancer patients 18 and older with neurotoxicity 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: Subscale domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Neurotoxicity 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/GOG-NTX , FACT/GOG-NTX-4 , FACT/GOG-NTX-13 , FACT-Taxane DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT/GOG-NTX-12 can be obtained by registering for permission. Users are not permitted to translate the FACT/GOG-NTX-12 without permission from FACIT.org. Permission from FACIT.org to translate the FACT/GOG-NTX-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 Almadrones L, McGuire DB, Walczak JR, Florio CM, Tian C. Psychometric evaluation of two scales assessing functional status and peripheral neuropathy associated with chemotherapy for ovarian cancer: A Gynecologic Oncology Group study. Oncol Nur Forum 2004; 31:615-623. Bao T, Goloubeva O, Pelser C, Porter N, Primrose J, Hester L, Sadowska M, Lapidus R, Medeiros M, Lao L, Dorsey SG, Badros AZ. A pilot study of acupuncture in treating bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Integr Cancer Ther. 2014; 13(5):396-404. Beijers A, Mols F, Dercksen W, Driessen C, Vreugdenhil G. Chemotherapy-induced peripheral neuropathy and impact on quality of life 6 months after treatment with chemotherapy. J Community Support Oncol. 2014; 12(11):401-6. Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005; 6:149-58. 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. Calhoun EA, Welshman EE, Chang CH, Lurain JR, Fishman DA, Hunt TL, Cella D. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity (FACT/GOG-NTX) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer 2003; 13:741-748. Cella D, Peterman A, Hudgens S, Webster K, Socinski MA. Measuring the side effects of taxane therapy in oncology: The Functional Assessment of Cancer Therapy – Taxane (FACT-Taxane). Cancer 2003; 98:822-831. Cho J, Kang D, Lee JY, Kim K, Kim SJ. Impact of dose modification on intravenous bortezomib-induced peripheral neuropathy in multiple myeloma patients. Support Care Cancer. 2014; 22(10):2669-75. Driessen CM, de Kleine-Bolt KM, Vingerhoets AJ, Mols F, Vreugdenhil G. Assessing the impact of chemotherapy-induced peripheral neurotoxicity on the quality of life of cancer patients: the introduction of a new measure. Support Care Cancer. 2012; 20(4):877-81. 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. Galantino ML, Callens ML, Cardena GJ, Piela NL, Mao JJ. Tai chi for well-being of breast cancer survivors with aromatase inhibitor-associated arthralgias: a feasibility study. Altern Ther Health Med. 2013; 19(6):38-44. Griffith KA, Merkies IS, Hill EE, Cornblath DR. Measures of chemotherapy-induced peripheral neuropathy: a systematic review of psychometric properties. J Peripher Nerv Syst. 2010; 15(4):314-25. Griffith KA, Couture DJ, Zhu S, Pandya N, Johantgen ME, Cavaletti G, Davenport JM, Tanguay LJ, Choflet A, Milliron T, Glass E, Gambill N, Renn CL, Dorsey SG. Evaluation of chemotherapy-induced peripheral neuropathy using current perception threshold and clinical evaluations. Support Care Cancer. 2014; 22(5):1161-9. Guo Y, Jones D, Palmer JL, Forman A, Dakhil SR, Velasco MR, Weiss M, Gilman P, Mills GM, Noga SJ, Eng C, Overman MJ, Fisch MJ. Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: a randomized, double-blind, placebo-controlled trial. Support Care Cancer. 2014; 22(5):1223-31. Han X, Wang L, Shi H, Zheng G, He J, Wu W, Shi J, Wei G, Zheng W, Sun J, Huang H, Cai Z. Acupuncture combined with methylcobalamin for the treatment of chemotherapy-induced peripheral neuropathy in patients with multiple myeloma. BMC Cancer. 2017;17(1):40. Hausheer FH, Schilsky RL, Bain S, Berghorn EJ, Lieberman F. Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol. 2006; 33(1):15-49. Hershman DL, Weimer LH, Wang A, Kranwinkel G, Brafman L, Fuentes D, Awad D, Crew KD. Association between patient reported outcomes and quantitative sensory tests for measuring long-term neurotoxicity in breast cancer survivors treated with adjuvant paclitaxel chemotherapy. Breast Cancer Res Treat. 2011; 125(3):767-74. Huang HQ, Brady MF, Cella D, Fleming G. Validation and reduction of FACT/GOG-NTX subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study. Int J Gynecol Cancer. 2007; 17:387-93. Kamimura T, Miyamoto T, Yokota N, Aoki T, Ito Y, Akashi K. Peripheral neuropathy exacerbated by lenalidomide in a patient with multiple myeloma. Intern Med. 2014; 53(15):1651-3. Kotaka M, Saito Y, Kato T, Satake H, Makiyama A, Tsuji Y, Shinozaki K, Fujiwara T, Mizushima T, Harihara Y, Nagata N, Kurihara N, Ando M, Kusakawa G, Sakai T, Uchida Y, Takamoto M, Kimoto S, Hyodo I. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy. Cancer Chemother Pharmacol. 2020 Sep 23. doi: 10.1007/s00280-020-04135-8. Epub ahead of print. PMID: 32965539. Kushner DM, Connor JP, Sanchez F, Volk M, Schink JC, Bailey HH, Harris LS, Stewart SL, Fine J, Hartenbach EM; For the Wisconsin Oncology Network. Weekly docetaxel and carboplatin for recurrent ovarian and peritoneal cancer: a phase II trial. Gynecol Oncol. 2007; 105:358-64. Land SR, Kopec JA, Cecchini RS, Ganz PA, Wieand HS, Colangelo LH, Murphy K, Kuebler JP, Seay TE, Needles BM, Bearden JD 3rd, Colman LK, Lanier KS, Pajon ER Jr, Cella D, Smith RE, O'Connell MJ, Costantino JP, Wolmark N. Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. J Clin Oncol 2007; 25:2205-11. Long HJ 3rd, Monk BJ, Huang HQ, Grendys EC Jr, McMeekin DS, Sorosky J, Miller DS, Eaton LA, Fiorica JV; Gynecologic Oncology Group. Clinical results and quality of life analysis for the MVAC combination (methotrexate, vinblastine, doxorubicin, and cisplatin) in carcinoma of the uterine cervix: A Gynecologic Oncology Group study. Gynecol Oncol. 2006; 100:537-43. McArthur JH. The reliability and validity of the subjective peripheral neuropathy screen. J Assoc Nurses AIDS Care. 1998; 9:84-94. Moore DH, Donnelly J, McGuire WP, Almadrones L, Cella D, Herzog TJ, Waggoner SE. Limited access trial using amifostine for protection against cisplatin- and three-hour paclitaxel-induced neurotoxicity: A Phase II study of the Gynecologic Oncology Group. J Clin Oncol 2003; 21:4207-4213. Ogawa K, Ogawa M, Nishijima K, Tsuda M, Nishimura G. Efficacy of contact needle therapy for chemotherapy-induced peripheral neuropathy. Evid Based Complement Alternat Med. 2013; 2013:928129. Oldenburg J, Fosså SD, Dahl AA. Scale for chemotherapy-induced long-term neurotoxicity (SCIN): psychometrics, validation, and findings in a large sample of testicular cancer survivors. Qual Life Res. 2006; 15:791-800. Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lantéri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005; 41:1135-9. Richardson PG, Briemberg H, Jagannath S, Wen PY, Barlogie B, Berenson J, Singhal S, Siegel DS, Irwin D, Schuster M, Srkalovic G, Alexanian R, Rajkumar SV, Limentani S, Alsina M, Orlowski RZ, Najarian K, Esseltine D, Anderson KC, Amato AA. Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. J Clin Oncol. 2006; 24:3113-20. Shimozuma K, Ohashi Y, Takeuchi A, Aranishi T, Morita S, Kuroi K, Ohsumi S, Makino H, Mukai H, Katsumata N, Sunada Y, Watanabe T, Hausheer FH. Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02. Support Care Cancer. 2009; 17(12):1483-91. Spigel DR, Patel JD, Reynolds CH, Garon EB, Hermann RC, Govindan R, Olsen M, Winfree KB, Liu J, Guba SC, Socinski MA, Bonomi P. Patient-reported outcomes from POINTBREAK: The randomized, open-label, phase III study of pemetrexed (pem) + carboplatin (cb) + bevacizumab (bev) followed by maintenance pem + bev versus paclitaxel (pac) + cb + bev followed by maintenance bev in patients with stage IIIb or IV nonsquamous non-small cell lung cancer (NS-NSCLC). J Clin Oncol. 2012; 30(34_suppl):53. [abstract] Vatandoust S, Joshi R, Pittman KB, Esterman A, Broadbridge V, Adams J, Singhal N, Yeend S, Price TJ. A descriptive study of persistent oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. Support Care Cancer. 2014; 22(2):513-8. Viala M, Bhakar AL, de la Loge C, van de Velde H, Esseltine D, Chang M, Dhawan R, Dubois D. Patient-reported outcomes helped predict survival in multiple myeloma using partial least squares analysis. J Clin Epidemiol. 2007; 60:670-679. Weber B, Largillier R, Ray-Coquard I, Yazbek G, Meunier J, Alexandre J, Dauba J, Spaeth D, Delva R, Joly F, Pujade-Lauraine E, Copel L; GINECO group, France. A potentially neuroprotective role for erythropoietin with paclitaxel treatment in ovarian cancer patients: a prospective phase II GINECO trial. Support Care Cancer. 2013; 21(7):1947-54. 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. Yamazaki K, Nagase M, Tamagawa H, Ueda S, Tamura T, Murata K, Eguchi Nakajima T, Baba E, Tsuda M, Moriwaki T, Esaki T, Tsuji Y, Muro K, Taira K, Denda T, Funai S, Shinozaki K, Yamashita H, Sugimoto N, Okuno T, Nishina T, Umeki M, Kurimoto T, Takayama T, Tsuji A, Yoshida M, Hosokawa A, Shibata Y, Suyama K, Okabe M, Suzuki K, Seki N, Kawakami K, Sato M, Fujikawa K, Hirashima T, Shimura T, Taku K, Otsuji T, Tamura F, Shinozaki E, Nakashima K, Hara H, Tsushima T, Ando M, Morita S, Boku N, Hyodo I. Randomized phase III study of bevacizumab plus FOLFIRI and bevacizumab plus mFOLFOX6 as first-line treatment for patients with metastatic colorectal cancer (WJOG4407G). Ann Oncol. 2016; 27(8):1539-46. 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. Zanville NR, Nudelman KN, Smith DJ, Von Ah D, McDonald BC, Champion VL, Saykin AJ. Evaluating the impact of chemotherapy-induced peripheral neuropathy symptoms (CIPN-sx) on perceived ability to work in breast cancer survivors during the first year post-treatment. Support Care Cancer. 2016; 24(11):4779-89. Zelman DC, Gore M, Dukes E, Tai KS, Brandenburg N. Validation of a modified version of the brief pain inventory for painful diabetic peripheral neuropathy. J Pain Symptom Manage. 2005; 29:401-10. LICENSE THIS MEASURE Related Measures Related Measures FACT/GOG-NTX Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity LEARN MORE FACT/GOG-NTX-4 Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 4 Item Version LEARN MORE FACT-Taxane Functional Assessment of Cancer Therapy – Taxane LEARN MORE

FACT-BRM Functional Assessment of Cancer Therapy - Biologic Response Modifiers For patients receiving Biologic Response Modifiers LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy – Biological Response Modifier (FACT-BRM) measures quality of life in cancer patients who are receiving treatment with biologic response modifiers. Using the FACT-G as a base, 17 additional items related to symptoms common to interferon and retinoid therapy were developed. Data collected at baseline (n = 191) and week 2 (n = 168) in a randomized trial of interferon ±13-cis-retinoic acid in advanced renal cell carcinoma patients were used to validate the instrument. Using a combined empirical and conceptual approach, the 17 items were reduced to 13 items consisting of two subscales: ‘BRM-physical’ (7 items) and ‘BRM-mental’ (6 items). Internal consistency of the trial outcome index (TOI) combining physical well-being, functional well-being and the BRM subscales, was 0.91 for baseline assessments and 0.92 for week 2. Discriminant validity was demonstrated for the TOI by its ability to differentiate among prognostic risk groups, and for the total FACT-G, TOI and total FACT–BRM scores by their ability to distinguish between groups differing in performance, response and toxicity status. MEASURE NAME: Functional Assessment of Cancer Therapy - Biologic Response Modifiers (FACT-BRM) VERSION: 4 NUMBER OF ITEMS: 40 PATIENT POPULATION: Cancer patients 18 years and older receiving treatment with biological response modifiers 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, BRM-Physical, BRM-Mental 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-BMT , FACT/GOG-NTX , FACT-G DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-BRM can be obtained by registering for permission. Users are not permitted to translate the FACT-BRM without permission from FACIT.org. Permission from FACIT.org to translate the FACT-BRM 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 Bacik, J., Mazumdar, M., Murphy, B., Fairclough, D., Eremenco, S., Mariani, T., Motzer, R., & Cella, D. The functional assessment of cancer therapy-BRM (FACT-BRM): A new tool for the assessment of quality of life in patients treated with biologic response modifiers. Quality of Life Research 2004; 13(1): 137-154. 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-BMT Functional Assessment of Cancer Therapy - Bone Marrow Transplantation LEARN MORE FACT/GOG-NTX Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity LEARN MORE FACT-G Functional Assessment of Cancer Therapy – General LEARN MORE

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