Overview
The Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) The FACT-Leu is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute
and chronic disease. Its development consisted of two phases: scale construction and scale validation. For the item-generation phase, a summary of the literature combined with qualitative results from item-generation interviews with 29 acute or chronic leukemia patients and 16 health care providers yielded an initial item pool reflecting leukemia-specific concerns and symptoms. Items underwent iterations of review and reduction according to defined retention criteria to support content validity, as defined by priority concerns of patients. Seventeen final leukemia-specific items were combined with the Functional Assessment of Cancer Therapy–General to create the FACT-Leukemia (FACT- Leu). For the validation phase, 79 individuals with acute or chronic leukemia completed measures at three time points. Leu subscale and aggregated scores showed high internal consistency (ranging from 0.75 to 0.96).Test-retest reliability was adequate for all subscales (intraclass correlation range 0.765–0.890).It demonstrated good convergent validity, with significant correlations with quality-of-life criteria and performance status, in the expected direction. FACT-Leu subscale scores were significantly different among the three performance status change groups, suggesting good responsiveness to change.
MEASURE NAME:
Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu)
VERSION:
4
NUMBER OF ITEMS:
44
PATIENT POPULATION:
Leukemia 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, Leukemia 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:
Language Availability
Available translations of the FACT-Leu can be obtained by registering for permission. Users are not permitted to translate the FACT-Leu without permission from FACIT.org. Permission from FACIT.org to translate the FACT-Leu 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
Cella, D., Jensen, S., Webster, K., Du, H., Lai, JS., Rosen, S., Tallman, M., & Yount, S. Measuring health-related quality of life in leukemia: the functional assessment of cancer therapy – leukemia (FACT-Leu) Questionnaire. Value in Health 2012; 15(8): 1051-1058. doi: 10.1016/j.jval.2012.08.2210.
Cella, D., Jensen, S., Webster, K., Du, H., Lai, JS., Rosen, S., Tallman, M., & Yount, S. Measuring health-related quality of life in leukemia: the functional assessment of cancer therapy – leukemia (FACT-Leu) Questionnaire. Value in Health 2012; 15(8): 1051-1058. doi: 10.1016/j.jval.2012.08.2210.
Efficace, F., Cardoni, A., Cottone, F., Vignetti, M. & Mandelli, F. Tyrosine-kinase inhibitors and patient-reported outcomes in chronic myeloid leukemia: A systematic review. Leukemia Research 2013; 37(2): 206-213. doi: 10.1016/j.leukres.2012.10.021.
Trask, P., Cella, D., Besson, N., Kelly, V., Masszi, T., Kim, D. Health-relate d quality of life of Bosutinib (SKI-606) in Imatinib-resistant or Imatinib-intolerant chronic phase chronic myeloid leukemia. Leukemia Research 2012; 36(4): 438-442. doi: 10.1016/j.leukres.2011.10.011.
Trask, P., Cella, D., Powell, C., Reisman, A., Whiteley, J., & Kelly, V. Health-related quality of life in chronic myeloid leukemia. Leukemia Research 2013; 37(1): 9-13. doi: 10.1016/j.leukres.2012.09.013.
Whiteley, J., Reisman, A., Shapiro, M., Cortes, J., & Cella, D. Health-related quality of life during bosutinib (SKI-606) therapy in patients with advanced chronic myeloid leukemia after imatinib failure. Current Medical Research & Opinion 2016; 32(8): 1325-1334. doi: 10.1185/03007995.2016.1174108.
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.
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