Overview
The Functional Assessment of Cancer Therapy – Bladder (FACT-Bl), is a 39 item instrument developed to measure five domains in bladder cancer patients: Physical, social, emotional, functional well-being, and a bladder cancer subscale. Recent validation with 182 patients with advanced urothelial cancer demonstrated its validity for use in clinical trials. Data were collected as part of a multicenter, open-label study of durvalumab in patients with inoperable or metastatic solid tumors. Psychometric properties evaluated include item and subscale characteristics (including correlation analysis), reliability (estimated using Cronbach’s alpha), validity (by independent sample t test), responsiveness (using mixed models with repeated measures), and clinically meaningful changes using both anchor-based and distribution-based methods. The psychometric properties of the existing established scales were assessed and found to range from acceptable to very good. The FACT-Bl subscale and total scores were responsive to changes in bladder cancer symptom severity, clinically meaningful changes in FACT-Bl scores were estimated, and the results support its use with bladder cancer patients.
MEASURE NAME:
Functional Assessment of Cancer Therapy – Bladder (FACT-Bl)
VERSION:
4
NUMBER OF ITEMS:
39
PATIENT POPULATION:
Bladder 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, Bladder Cancer Subscale
TIME FOR COMPLETION:
10-15 minutes
SCORING:
Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI possible. SAS/SPSS algorithms available.
RELATED MEASURES:
Language Availability
Available translations of the FACT-Bl can be obtained by registering for permission. Users are not permitted to translate the FACT-Bl without permission from FACIT.org. Permission from FACIT.org to translate the FACT-Bl 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
Degboe A., Ivanescu C., Rohay J.M., Turner R.R., Cella D. Validity and performance of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) among advanced urothelial cancer patients. Supportive Care in Cancer 2019.
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.
Botteman M.F., Pashos C.L., Hauser R.S., Laskin B.L., Redaelli A. Quality of life aspects of bladder cancer: A review of the literature. Quality of Life Research 2003; 12: 675-688.
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.
Karvinen K.H., Courneya K.S., North S., Venner P. Associations between exercise and quality of life in bladder cancer survivors: A population-based study. Cancer Epidemiology, Biomarkers & Prevention 2007; 16(5): 984-990.
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.
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