Overview
The single FACT-G item, GP5, “I am bothered by side effects of treatment,” is a summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of adverse events in clinical trials. The single item has demonstrated a significant relationship to overall quality of life as indicated by ability to enjoy life. It has been aligned with the current Food and Drug Administration interest in evaluating the patient’s perspective on treatment of adverse events, and it has been shown to be significantly associated with clinician-reported adverse events.
MEASURE NAME:
Functional Assessment of Chronic Illness Therapy - Item GP5
VERSION:
4
NUMBER OF ITEMS:
1
PATIENT POPULATION:
Patients 18 years and older receiving 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:
None
TIME FOR COMPLETION:
Less than 1 minute
SCORING:
Single score
RELATED MEASURES:
Language Availability
Available translations of item GP5 can be obtained by registering for permission. Users are not permitted to translate item GP5 without permission from FACIT.org. Permission from FACIT.org to translate item GP5 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.
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.
Selected References
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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.
Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Özgüroğlu M, Juárez Soto Á, Merseburger AS, Uemura H, Ye D, Given R, Cella D, Basch E, Miladinovic B, Dearden L, Deprince K, Naini V, Lopez-Gitlitz A, Chi KN; TITAN investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019 Nov;20(11):1518-1530. doi: 10.1016/S1470-2045(19)30620-5. Epub 2019 Sep 29. PMID: 31578173.
Arizmendi C, Zhu Y, Khan M, Gable J, Reeve BB, King-Kallimanis B, Bell J. The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments. Qual Life Res. 2024 Oct;33(10):2869-2880. doi: 10.1007/s11136-024-03740-x. Epub 2024 Jul 24. PMID: 39046616; PMCID: PMC11452438.
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.
Brucker P.S., Yost K., Cashy J., Webster K., Cella D. General population and cancer patient norms for the Functional Assessment of Cancer Therapy – General (FACT-G). Evaluation & the Health Professions 2005; 28(2): 192-211.
Cella D, Escudier B, Rini B, Chen C, Bhattacharyya H, Tarazi J, Rosbrook B, Kim S, Motzer R. Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial. British Journal of Cancer 2013; 108: 1571-78.
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Eremenco, S., Arnold, B., Cella, D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions2005; 28(2): 212-232.
Gharzai LA, Mierzwa ML, Stepan KO, Cella D, Peipert JD. Validity of a single-item indicator of treatment side effect bother in patients with head and neck cancer. Support Care Cancer. 2024 Aug 6;32(9):575. doi: 10.1007/s00520-024-08775-x. PMID: 39107440.
Griffiths P, Peipert JD, Leith A, Rider A, Morgan L, Cella D, Cocks K. Validity of a single-item indicator of treatment side effect bother in a diverse sample of cancer patients. Support Care Cancer. 2022 Apr;30(4):3613-3623. doi: 10.1007/s00520-022-06802-3. Epub 2022 Jan 14. PMID: 35031830; PMCID: PMC8857159.
Hahn E, Glendenning A, Sorensen M, Hudgense S, Druker B, Guilhot F, Larson R, O’Brien S, Dobrez D, Hensley M, Cella D. Quality of life in patients with newly diagnosed chronic myeloid leukemia on imatinib versus interferon plus low-dose ARA-C: results from the IRIS study. J Clin Oncol 2003; 21(11): 2138-2146.
O'Connell NS, Zhao F, Lee JW, Ip EH, Peipert JD, Graham N, Smith ML, Gareen IF, Carlos RC, Obeng-Gyasi S, Sparano JA, Shanafelt TD, Thomas ML, Cella D, Wagner LI, Gray R. Importance of Low- and Moderate-Grade Adverse Events in Patients' Treatment Experience and Treatment Discontinuation: An Analysis of the E1912 Trial. J Clin Oncol. 2024 Jan 20;42(3):266-272. doi: 10.1200/JCO.23.00377. Epub 2023 Oct 6. PMID: 37801678; PMCID: PMC10824381.
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.
Peipert JD, Zhao F, Lee J, et al. Patient-Reported Adverse Events and Early Treatment Discontinuation Among Patients With Multiple Myeloma. JAMA Netw Open. 2024;7(3):e243854. doi:10.1001/jamanetworkopen.2024.3854
Peipert JD, Zhao F, Lee JW, Shen SE, Ip E, O'Connell N, Carlos RC, Graham N, Smith ML, Gareen IF, Raper PJ, Weiss M, Kumar SK, Rajkumar SV, Cella D, Gray R, Wagner LI. Patient-Reported Adverse Events and Early Treatment Discontinuation Among Patients With Multiple Myeloma. JAMA Netw Open. 2024 Mar 4;7(3):e243854. doi: 10.1001/jamanetworkopen.2024.3854. PMID: 38536173; PMCID: PMC10973895.
Peipert JD, Shaunfield S, Kaiser K, Moreno PI, Fox RS, Kircher S, Mohindra N, Ip E, Zhao F, Wagner L, Cella D. How do patients interpret and respond to a single-item global indicator of cancer treatment tolerability? Support Care Cancer. 2022 Dec 16;31(1):37. doi: 10.1007/s00520-022-07484-7. Erratum in: Support Care Cancer. 2023 Jul 24;31(8):489. doi: 10.1007/s00520-023-07953-7. PMID: 36525100; PMCID: PMC10356672.
Peipert J.D., Cella D. Bifactor analysis confirmation of the factorial structure of the Functional Assessment of Cancer Therapy – General (FACT-G). Psycho-Oncology 2019; 28: 1149-1152.
Regnault, A., Bunod, L., Loubert, A. et al. Assessing tolerability with the Functional Assessment of Cancer Therapy item GP5: psychometric evidence from LIBRETTO-531, a phase 3 trial of selpercatinib in medullary thyroid cancer. J Patient Rep Outcomes 8, 149 (2024). https://doi.org/10.1186/s41687-024-00823-8.
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Saad F, Cella D, Basch E, Hadaschik BA, Mainwaring PN, Oudard S, Graff JN, McQuarrie K, Li S, Hudgens S, Lawson J, Lopez-Gitlitz A, Yu MK, Smith MR, Small EJ. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1404-1416. doi: 10.1016/S1470-2045(18)30456-X. Epub 2018 Sep 10. PMID: 30213449.
Wagner LI, Zhao F, Goss PE, Chapman JW, Shepherd LE, Whelan TJ, Mattar BI, Bufill JA, Schultz WC, LaFrancis IE, Nagargoje GG, Vemuri R, Nikcevich DA, Sledge GW, Cella D. Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03). Breast Cancer Res Treat. 2018 Jun;169(3):537-548. doi: 10.1007/s10549-018-4713-2. Epub 2018 Feb 17. PMID: 29455298; PMCID: PMC6092930.
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