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Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument.
Abstract
PURPOSE: This is the first published report on the validation of the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer. The FACT-B consists of the FACT-General (FACT-G) plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to QL in breast cancer. The FACT-B was developed with an emphasis on patients' values and brevity and is available in nine languages. METHODS AND RESULTS: Two validation samples were used for this report. The first (n = 47) was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample (n = 295). The alpha coefficient (internal consistency) for the FACT-B total score was high (alpha = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. CONCLUSION: The FACT-B is appropriate for use in oncology clinical trials, as well as in clinical practice. It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change.
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“Important secondary outcomes were the other three physical component subscales of the SF-36 (role–physical, bodily pain, and general health), the physical component summary, the trial outcome index–fatigue (7), breast cancer symptoms (8), fatigue symptoms (7), taxane/neuropathy symptoms (9), and endocrine symptoms (10…”
BackgroundFatigue, sleep, and circadian rhythms prior to chemotherapy for breast cancer
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Self-citationSymptoms in Adults with Lung Cancer
Cooley, M. E. (2000) · Journal of Pain and Symptom Management · doi:10.1016/s0885-3924(99)00150-5 · Cited by 288
Haller, H., Winkler, M. M., Klose, P., Dobos, G., Kümmel, S., & Cramer, H. (2017) · Acta Oncologica · doi:10.1080/0284186x.2017.1342862 · Cited by 277
Ellis, M. J., Gao, F., Dehdashti, F., Jeffe, D. B., Marcom, P. K., Carey, L., Dickler, M. N., Silverman, P., Fleming, G. F., Kommareddy, A., et al. (2009) · JAMA · doi:10.1001/jama.2009.1204 · Cited by 287
“Median (range) follow-up time was 83 (37-215) weeks for the 6-mg group and 86 (6-212) weeks for the 30-mg group.”
Crew, K. D., Capodice, J. L., Greenlee, H., Brafman, L., Fuentes, D., Awad, D., Tsai, W. Y., & Hershman, D. L. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.23.4708 · Cited by 292
Demark‐Wahnefried, W., Clipp, E. C., Lipkus, I. M., Lobach, D. F., Snyder, D. C., Sloane, R. J., Peterson, B. L., Macri, J. M., Rock, C. L., McBride, C. M., et al. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2007.10.7094 · Cited by 290
Carlson, L. E., Doll, R., Stephen, J., Faris, P., Tamagawa, R., Drysdale, E., & Speca, M. (2013) · Journal of Clinical Oncology · doi:10.1200/jco.2012.47.5210 · Cited by 282
Reliability and validity of the functional assessment of cancer therapy-ovarian
Basen-Engquist, K., Bodurka-Bevers, D., Fitzgerald, M. A., Webster, K., Cella, D., Hu, S., & Gershenson, D. M. (2001) · Journal of Clinical Oncology · doi:10.1200/jco.2001.19.6.1809 · Cited by 280
Self-citationHeffernan, N., Cella, D. F., Webster, K., Odom, L., Martone, M. W., Passik, S. D., Bookbinder, M., Fong, Y., Jarnagin, W. R., & Blumgart, L. H. (2002) · Journal of Clinical Oncology · doi:10.1200/jco.2002.07.093 · Cited by 280
Self-citationCella, D. F., & Nowinski, C. J. (2002) · Archives of Physical Medicine and Rehabilitation · doi:10.1053/apmr.2002.36959 · Cited by 279
Self-citationMoadel, A. B., Morgan, C., Fatone, A., Grennan, J., Carter, J., LaRuffa, G. M., Skummy, A., & Dutcher, J. P. (1999) · Psycho-Oncology · doi:10.1002/(sici)1099-1611(199909/10)8:5 · Cited by 413
Self-citationExercise Interventions for Cancer Survivors: A Meta-Analysis of Quality of Life Outcomes
Ferrer, R. A., Huedo-Medina, T. B., Johnson, B. T., Ryan, S. M., & Pescatello, L. S. (2010) · Annals of Behavioral Medicine · doi:10.1007/s12160-010-9225-1 · Cited by 282
Quality of life and breast cancer: Relationship to psychosocial variables
Shapiro, S. L., López, A. M., Schwartz, G. E., Bootzin, R. R., Figueredo, A. J., Braden, C. J., & Kurker, S. F. (2001) · Journal of Clinical Psychology · doi:10.1002/jclp.1026 · Cited by 269
“The FACIT-B is comprised of five areas of quality of life: physical well being, social/family well-being, emotional well-being, and functional wellbeing, and nine additional items specifically related to breast cancer.”
BackgroundShaitelman, S. F., Schlembach, P. J., Arzu, I., Ballo, M. T., Bloom, E. S., Buchholz, D. J., Chronowski, G. M., Dvořák, T., Grade, E., Hoffman, K. E., et al. (2015) · JAMA Oncology · doi:10.1001/jamaoncol.2015.2666 · Cited by 269
The Epidemiology of Arm and Hand Swelling in Premenopausal Breast Cancer Survivors
Paskett, E. D., Naughton, M. J., McCoy, T. P., Case, L. D., & Abbott, J. M. (2007) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-06-0168 · Cited by 266
Porter, L. S., Keefe, F. J., Garst, J. L., McBride, C. M., & Baucom, D. H. (2007) · Pain · doi:10.1016/j.pain.2007.09.010 · Cited by 264
Pusic, A. L., Chen, C. M., Cano, S., Klassen, A. F., McCarthy, C. M., Collins, E. D., & Cordeiro, P. G. (2007) · Plastic & Reconstructive Surgery · doi:10.1097/01.prs.0000278162.82906.81 · Cited by 260
Thewes, B., Meiser, B., Taylor, A., Phillips, K., Pendlebury, S. T., Capp, A., Dalley, D. N., Goldstein, D., Baber, R., & Friedlander, M. L. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.07.773 · Cited by 257
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“QOL was measured using the Functional Assessment of Cancer Therapy Scale} Breast (FACT-B) [22], a 44-item measure specific to breast cancer (Cronbach0s alpha 1⁄4 0:88).”
MethodResultCella, D. F., Fallowfield, L. J., Barker, P. N., Cuzick, J. M., Locker, G. Y., Howell, A., & On behalf of the ATAC Trialistsȁ9 Group (2006) · Breast Cancer Research and Treatment · doi:10.1007/s10549-006-9260-6 · Cited by 251
Self-citationImpact of BRCA1/BRCA2 counseling and testing on newly diagnosed breast cancer patients.
Schwartz, M. D., Lerman, C., Brogan, B. M., Peshkin, B., Halbert, C., Demarco, T. A., Lawrence, W., Main, D., Finch, C., Magnant, C., et al. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2004.04.086 · Cited by 248
Goodwin, P. J., Black, J., Bordeleau, L. J., & Ganz, P. A. (2003) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/95.4.263 · Cited by 250
Multicenter Phase II Trial of Weekly Paclitaxel in Women With Metastatic Breast Cancer
Perez, E. A., Vogel, C. L., Irwin, D. H., Kirshner, J. J., & Patel, R. (2001) · Journal of Clinical Oncology · doi:10.1200/jco.2001.19.22.4216 · Cited by 248
Differences in patterns of depression after treatment for breast cancer
Deshields, T. L., Tibbs, T. L., Fan, M., & Taylor, M. (2005) · Psycho-Oncology · doi:10.1002/pon.962 · Cited by 245
“05) than the established norm for adults (X ¼ 9:25) (Brady et al., 1997).”
BackgroundInfluentialDemark‐Wahnefried, W., Clipp, E. C., Morey, M. C., Pieper, C. F., Sloane, R. J., Snyder, D. C., & Cohen, H. J. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2006.05.7224 · Cited by 243
Sexual Problems in Younger Women After Breast Cancer Surgery
Burwell, S. R., Case, L. D., Kaelin, C. M., & Avis, N. E. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2005.04.2499 · Cited by 240
A comprehensive geriatric intervention detects multiple problems in older breast cancer patients
Extermann, M. (2003) · Critical Reviews in Oncology/Hematology · doi:10.1016/s1040-8428(03)00099-4 · Cited by 238
“1) The end-points planned for the main trial: change in dependence in ADL [7]; change in living conditions; change in QOL (FACT-B) [5].”
BackgroundMethodBillingsley, K. G., Maynard, C. C., Schwartz, D. L., & Dominitz, J. A. (2001) · Cancer · doi:10.1002/1097-0142(20010901)92:5 · Cited by 11
Self-citationEffect of cosmetic outcome on quality of life after breast cancer surgery
Kim, M., Kim, T. Y., Moon, H., Jin, U. S., Kim, K. J., Kim, J. H., Lee, J. W., Kim, J. H., Lee, E., Yoo, T. K., et al. (2014) · European Journal of Surgical Oncology · doi:10.1016/j.ejso.2014.12.002 · Cited by 234
Social networks, social support mechanisms, and quality of life after breast cancer diagnosis
Kroenke, C. H., Kwan, M. L., Neugut, A. I., Ergas, I. J., Wright, J. D., Caan, B. J., Hershman, D., & Kushi, L. H. (2013) · Breast Cancer Research and Treatment · doi:10.1007/s10549-013-2477-2 · Cited by 233
Dance and Movement Program Improves Quality-of-Life Measures in Breast Cancer Survivors
Sandel, S. L., Judge, J. O., Landry, N., Faria, L., Ouellette, R., & Majczak, M. (2005) · Cancer Nursing · doi:10.1097/00002820-200507000-00011 · Cited by 232
“8 standard deviation of the distribution of the FACT-B score at baseline in our sample and in the large sample of women in the FACT-B validation study.(19) The experience of the control group during the crossover portion of the trial was similar to the experience of the intervention group in the first portion of the t…”
MethodResultInfluentialRestorative yoga for women with breast cancer: findings from a randomized pilot study
Danhauer, S. C., Mihalko, S. L., Russell, G. B., Campbell, C. R., Felder, L., Daley, K., & Levine, E. A. (2009) · Psycho-Oncology · doi:10.1002/pon.1503 · Cited by 285
“(FACT-B) [26]”
Härtl, K., Janni, W., Kästner, R., Sommer, H., Strobl, B., Rack, B. K., & Stauber, M. (2003) · Annals of Oncology · doi:10.1093/annonc/mdg289 · Cited by 229
“However, one has to keep in mind that other workers, including the EORTC study group, have developed scales specific to breast cancer, for example a breast cancer version of the Rotterdam Symptom Checklist [23], the Functional Assessment of Cancer Therapy—Breast [24] and the breast cancer module of the EORTC to be use…”
MethodZhang, L., Ma, S., Song, X., Han, B., Cheng, Y., Huang, C., Yang, S., Liu, X., Liu, Y., Lü, S., et al. (2012) · The Lancet Oncology · doi:10.1016/s1470-2045(12)70117-1 · Cited by 228
Quality of Life in Breast Cancer Patients—Not Enough Attention for Long-Term Survivors?
Holzner, B., Kemmler, G., Kopp, M., Moschèn, R., Schweigkofler, H., Nser, M. D., Margreiter, R., Fleischhacker, W., & Sperner‐Unterweger, B. (2001) · Psychosomatics · doi:10.1176/appi.psy.42.2.117 · Cited by 227
Metadata
- Authors
- Brady, M. J., Cella, D. F., Mo, F., Bonomi, A. E., Tulsky, D. S., Lloyd, S. R., Deasy, S., Cobleigh, M., & Shiomoto, G.
- Affiliations
- Rush University Medical Center (US)
- Rush University (US)
- Venue
- Journal of Clinical Oncology
- Published
- 1997-03
- Volume
- 15
- Issue
- 3
- Pages
- 974-986
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W1857624176
- Cited by
- 1,752
- References
- 39
- Citations by year
- 2026: 47 · 2025: 76 · 2024: 77 · 2023: 71 · 2022: 97 · 2021: 88 · 2020: 78 · 2019: 87 · 2018: 83 · 2017: 85 · 2016: 83 · 2015: 73 · 2014: 83 · 2013: 70 · 2012: 86
- FWCI
- 5.28
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (1r29ca051926-01a1)
- National Cancer Institute (R29CA51926)
- Topics
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Nursing › Research and Theory › Health Education and Validation
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- FACT-B, breast cancer, quality of life, FACT-G, instrument validation, sensitivity to change, test-retest reliability, internal consistency, known-groups validity, convergent validity, discriminant validity, physical well-being, functional well-being, emotional well-being, Functional Living Index-Cancer, self-report questionnaire
- MeSH terms
- Adult, Aged, Aged, 80 and over, Breast Neoplasms, Female, Humans, Middle Aged, Quality of Life, Self Concept, Sensitivity and Specificity, Severity of Illness Index, Translations, Reproducibility of Results
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