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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The observed mean improvements in QoL exceeded the suggested clinically meaningful threshold of 7-8 points on the FACT-B for both groups.
“The observed mean improvements presented within this evaluation exceeded this for both groups.”
All measures were validated, brief, and non-redundant.
“All measures were validated, brief, and non-redundant, supporting parsimony while enabling comprehensive evaluation of intervention impact.”
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MethodQuality of Life of Women With Recurrent Breast Cancer and Their Family Members
Northouse, L., Mood, D., Kershaw, T., Schafenacker, A., Mellon, S., Walker, J. G., Galvin, E. A., & Decker, V. B. (2002) · Journal of Clinical Oncology · doi:10.1200/jco.2002.02.054 · Cited by 403 · see citing works
Bonomi, A. E., Cella, D. F., Hahn, E. A., Bjordal, K., Sperner‐Unterweger, B., Gangeri, L., Bergman, B., Willems-Groot, J., Hanquet, P., & Zittoun, R. (1996) · Quality of Life Research · doi:10.1007/bf00433915 · Cited by 399 · see citing works
Self-citationHoffman, C. J., Ersser, S. J., Hopkinson, J. B., Nicholls, P. G., Harrington, J. E., & Thomas, P. W. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2010.34.0331 · Cited by 398 · see citing works
“Soulsby, personal communication, May 2003).(29,30,32-35)”
Moadel, A. B., Shah, C. D., Wylie‐Rosett, J., Harris, M. S., Patel, S. R., Hall, C. B., & Sparano, J. A. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.06.6027 · Cited by 398 · see citing works
“The FACT has been administered successfully in an interview format(61) and has been shown to have high reliability, validity, and sensitivity to change.(60,62-64) The Functional Assessment of Chronic Illness Therapy–Fatigue(65) was used to assess limitations in daily activity and energy level.”
MethodEton, D. T., Cella, D., Yost, K. J., Yount, S. E., Peterman, A. H., Neuberg, D. S., Sledge, G. W., & Wood, W. C. (2004) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2004.01.012 · Cited by 390 · see citing works
“Breast cancer–specific modules have also been developed to supplement the EORTC QLQ-C30 [22] and the FACT [12].”
BackgroundMethodInfluentialSelf-citationHurvitz, S. A., Dirix, L. Y., Kocsis, J., Bianchi, G., Lu, J. M., Vinholes, J., Guardino, E., Song, C., Tong, B., Ng, V., et al. (2013) · Journal of Clinical Oncology · doi:10.1200/jco.2012.44.9694 · Cited by 390 · see citing works
Effect of computer support on younger women with breast cancer
Gustafson, D. H., Hawkins, R., Pingree, S., McTavish, F., Arora, N. K., Mendenhall, J., Cella, D. F., Serlin, R. C., Apantaku, F. M., Stewart, J., et al. (2001) · Journal of General Internal Medicine · doi:10.1046/j.1525-1497.2001.016007435.x · Cited by 387 · see citing works
Self-citationYost, K. J., & Eton, D. T. (2005) · Evaluation & the Health Professions · doi:10.1177/0163278705275340 · Cited by 382 · see citing works
“5 (Brady et al., 1997), the researcher would need 100 patients per group (Elashoff, 2000).”
BackgroundMethodInfluentialCella, D. F., Eton, D. T., Fairclough, D. L., Bonomi, P., Heyes, A., Silberman, C., Wolf, M. S., & Johnson, D. A. (2002) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(01)00477-2 · Cited by 381 · see citing works
Self-citationRisk factors for acute pain and its persistence following breast cancer surgery
Katz, J., Poleshuck, E. L., Andrus, C. H., Hogan, L. A., Jung, B. F., Kulick, D. I., & Dworkin, R. H. (2005) · Pain · doi:10.1016/j.pain.2005.09.008 · Cited by 363 · see citing works
“Disease-specific emotional functioning was assessed with three measures: the Functional Assessment of Cancer Treatment— Emotional scale (FACT-E; Brady et al., 1997; Cella et al., 1993), which was designed to assess mood and anxiety in patients with cancer; the Somatosensory Amplification Scale…”
MethodUpper‐body morbidity after breast cancer
Hayes, S. C., Johansson, K. I., Stout, N. L., Prosnitz, R., Armer, J. M., Gabram, S. G. A., & Schmitz, K. H. (2012) · Cancer · doi:10.1002/cncr.27467 · Cited by 360 · see citing works
Health state utilities for metastatic breast cancer
Lloyd, A. J., Nafees, B., Narewska, J., Dewilde, S., & Watkins, J. (2006) · British Journal of Cancer · doi:10.1038/sj.bjc.6603326 · Cited by 357 · see citing works
“The review also highlighted how frequently disease-specific measures, such as the FACT-B (Brady et al, 1997) and European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire-BR23 (Sprangers et al, 1996), had been used.”
BackgroundMethodFallowfield, L. J., Leaity, S. K., Howell, A., Benson, S., & Cella, D. F. (1999) · Breast Cancer Research and Treatment · doi:10.1023/a:1006263818115 · Cited by 355 · see citing works
Self-citationShapiro, S. L., Bootzin, R. R., Figueredo, A. J., Lopez, A. M., & Schwartz, G. E. (2003) · Journal of Psychosomatic Research · doi:10.1016/s0022-3999(02)00546-9 · Cited by 350 · see citing works
“The psychological measures used included: Profile of Mood States Scale (POMS) [21], the Beck Depression Inventory (BDI) [22], the Penn State Worry Questionnaire (PENN) [23], the State-Trait Anxiety Inventory [24], the Functional Assessment of Cancer Treatment-Breast (FACIT-B) [25], the Shapiro Control Inventory (SCI)…”
MethodMeaning in life and physical health: systematic review and meta-analysis
Czekierda, K., Banik, A., Park, C. L., & Łuszczyńska, A. (2017) · Health Psychology Review · doi:10.1080/17437199.2017.1327325 · Cited by 348 · see citing works
“Subjective assessment of health status by means of standardised scales included the following measures: Physical Health Status and Functioning subscales of Medical Outcomes Study (MOS) Short Form 12 (SF-12) (Stewart, Hays, & Ware, 1988; Ware & Sherbourne, 1992; Ware, Kosinski, & Keller, 1996); Physical Functioning sub…”
BackgroundInfluentialNorthouse, L., Kershaw, T., Mood, D., & Schafenacker, A. (2005) · Psycho-Oncology · doi:10.1002/pon.871 · Cited by 338 · see citing works
“Adequate reliability and validity of the FACT scales, and SF 36 have been reported previously (Brady et al., 1997; Cella et al., 1993; Ware et al., 1994).”
BackgroundKong, F., Jirtle, R. L., Huang, D. H., Clough, R. W., & Anscher, M. S. (1999) · Cancer · doi:10.1002/(sici)1097-0142(19991101)86:9 · Cited by 133 · see citing works
Self-citationVallance, J. K., Courneya, K. S., Plotnikoff, R. C., Yasui, Y., & Mackey, J. R. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.07.9988 · Cited by 326 · see citing works
“QoL was assessed by the Functional Assessment of Cancer Therapy– Breast (FACT-B) scale.(18,19) Fatigue was assessed using the Fatigue Scale(20) from the FACT measurement system.”
MethodFallowfield, L. J., Cella, D. F., Cuzick, J. M., Francis, S., Locker, G. Y., & Howell, A. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2004.08.029 · Cited by 310 · see citing works
Self-citationLymphedema and Quality of Life in Survivors of Early-Stage Breast Cancer
Beaulac, S. M. (2002) · Archives of Surgery · doi:10.1001/archsurg.137.11.1253 · Cited by 308 · see citing works
“tions regarding breast, emotional, functional, physical, and social well-being.(2) The FACT-B uses the 5-point Likert scale (each”
MethodEffects of exercise dose and type during breast cancer chemotherapy: multicenter randomized trial
Courneya, K. S., McKenzie, D. C., Mackey, J. R., Gelmon, K., Friedenreich, C. M., Yasui, Y., Reid, R. D., Cook, D., Jespersen, D., Proulx, C., et al. (2013) · JNCI: Journal of the National Cancer Institute · doi:10.1093/jnci/djt297 · Cited by 297 · see citing works
“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
Ancoli‐Israel, S., Liu, L., Marler, M., Parker, B. A., Jones, V. E., Sadler, G. R., Dimsdale, J. E., Cohen‐Zion, M., & Fiorentino, L. (2005) · Supportive Care in Cancer · doi:10.1007/s00520-005-0861-0 · Cited by 306 · see citing works
Schiller, J. H., Adak, S., Cella, D. F., DeVore, R. F., & Johnson, D. H. (2001) · Journal of Clinical Oncology · doi:10.1200/jco.2001.19.8.2114 · Cited by 294 · see citing works
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 · see citing works
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 · see citing works
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 · see citing works
“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 286 · see citing works
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 284 · see citing works
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 · see citing works
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 · see citing works
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 · see citing works
Self-citationCella, D. F., & Nowinski, C. J. (2002) · Archives of Physical Medicine and Rehabilitation · doi:10.1053/apmr.2002.36959 · Cited by 273 · see citing works
Self-citationRe-creating your life: a spiritual/psychotherapeutic intervention for people diagnosed with cancer
Cole, B. S., & Pargäment, K. I. (1999) · Psycho-Oncology · doi:10.1002/(sici)1099-1611(199909/10)8:5 · Cited by 160 · see citing works
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 272 · see citing works
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 · see citing works
“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 · see citing works
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 · see citing works
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 · see citing works
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 259 · see citing works
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 · see citing works
Morrill, E. F., Brewer, N. T., O’Neill, S. C., Lillie, S. E., Dees, E. C., Carey, L., & Rimer, B. K. (2008) · Psycho-Oncology · doi:10.1002/pon.1313 · Cited by 254 · see citing works
“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 · see citing works
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 · see citing works
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 247 · see citing works
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 · see citing works
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 · see citing works
“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 · see citing works
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 · see citing works
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 · see citing works
“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].”
BackgroundMethodSaji, H., Koike, M., Yamori, T., Saji, S., Seiki, M., Matsushima, K., & Toi, M. (2001) · Cancer · doi:10.1002/1097-0142(20010901)92:5 · Cited by 283 · see citing works
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 · see citing works
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 · see citing works
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 · see citing works
“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 · see citing works
“(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 · see citing works
“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 227 · see citing works
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 · see citing works
- 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
- Social Sciences › Education › 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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