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
Pearman T.P., Beaumont J.L., Mroczek D., O'Connor M., Cella D. Validity and usefulness of a single-item measure of patient-reported bother from side effects of cancer therapy. Cancer 2018 Mar 1;124(5):991-997. doi: 10.1002/cncr.31133. Epub 2017 Nov 13. PMID: 29131323; PMCID: PMC5892190.
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.
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.
Cella D., Hahn E., Dineen K. Meaningful change in cancer-specific quality of life scores: Differences between improvement and worsening. Quality of Life Research 2002; 11(3): 207-21.
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.
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.
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 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 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.
Wagner L, Zhao F, Chapman J, Cella D, Shepherd L, Sledge G, Goss P. Patient-reported predictors of early treatment discontinuation: NCIC JMA.27/E1Z03 Quality of life study of postmenopausal women with primary breast cancer randomized to exemestane or anastrozole. Cancer Res 2011; 71(24S): Abstract S6-2.
Yost K.J., Eton D.T. Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Evaluation & the Health Professions2005; 28(2): 172-191.
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