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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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“The psychometric properties of the FACTB are well documented [25], and the survey was validated in Korea [26].”
Development of the Novel Biologically Targeted Anticancer Agent Gefitinib
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“responses in 5 dimensions on a 5-point Likert scale [50,51].”
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“The validated local language (Malayalam) version (13) of the Functional Assessment of Cancer TherapyBreast (FACT-B) (Version 4) (14) was used.”
MethodA prospective study of breast lymphedema: frequency, symptoms, and quality of life
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“QOL was evaluated with the FACT-B scale [11].”
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“These results indicate that change in social support also partially medi- Table 2 Effect of MBCR (n = 69) versus SET (n = 70) on study variables Time 1 Time 2 pA Cohen’s d M (SD) M (SD) Mood disturbance (POMS) MBCR 33.62 (31.86) 14.48 (26.72) .004 .34 SET 36.30 (37.47) 28.85 (39.14) Stress symptoms (CSOSI) MBCR 67.98…”
MethodInfluentialAnxiety, Depression and Quality of Life in Breast Cancer Patients in the Levant
Akel, R., Darsa, H. E., Anouti, B., Mukherji, D., Temraz, S. N., Raslan, R., Tfayli, A., & Assi, H. I. (2017) · PubMed Central · doi:10.22034/apjcp.2017.18.10.2809 · Cited by 62
“It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change (Brady et al., 1997).”
BackgroundQuality of life measurement Will we ever be satisfied?
Bonomi, A. E., Patrick, D. L., Bushnell, D. M., & Martin, M. (2000) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(99)00121-3 · Cited by 63
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“All studies employed a range of validated HRQOL measurement tools, including the Psychological Adjustment to Illness Scale [48], Interpersonal Support Evaluation List [49], Quality of Life/Breast Cancer Psychological Well-Being Subscale [18, 19], Functional Assessment of Cancer Therapy-Breast [50], Quality of Life in…”
MethodBelmonte, R., Messaggi-Sartor, M., Ferrer, M., Pont, À., & Escalada, F. (2018) · Supportive Care in Cancer · doi:10.1007/s00520-018-4186-1 · Cited by 68
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“Higher scores indicate a better quality of life [52,54,55].”
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“FACT-B is a 37- item instrument assessing the impact of breast cancer and chemotherapy on dimensions of QoL.”
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Systematic Review of Breast-Q: A Tool to Evaluate Post-Mastectomy Breast Reconstruction
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Pilot Evaluation of an Iyengar Yoga Program for Breast Cancer Survivors
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“This item is part of the Functional Assessment of Cancer Therapy survey.(8,9) Scores were linearly transformed to a 0–100 scale.”
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Depression, anxiety and disease-related distress in couples affected by advanced lung cancer
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Determinants of quality of life of bladder cancer survivors five years after treatment in France
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“In the current study, we employed two widely used QOL questionnaires (FACT-B and EQ-5D) [6, 20] to assess the effects of treatment with L ? C or C alone on patients’ QOL.”
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The Satisfaction with Life Domains Scale for Breast Cancer (SLDS-BC)
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Dieli-Conwright, C. M., Mortimer, J. E., Schroeder, E. T., Courneya, K. S., Demark‐Wahnefried, W., Buchanan, T. A., Tripathy, D., & Bernstein, L. (2014) · BMC Cancer · doi:10.1186/1471-2407-14-238 · Cited by 60
“The FACT-B (Functional Assessment of Cancer Therapy-Breast) is a breast cancer-specific questionnaire comprised of 44 items to specifically assess quality of life in breast cancer patients [57].”
BackgroundHeath-related quality of life in Spanish breast cancer patients: a systematic review
Delgado‐Sanz, C., García-Mendizábal, M. J., Pollán, M., Forjaz, M. J., López‐Abente, G., Aragonés, N., & Pérez‐Gómez, B. (2011) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-9-3 · Cited by 59
“The FACTB displays good reliability, validity and sensitivity to change [45].”
BackgroundHealth-Related Quality of Life of Food-Insecure Ethnic Minority Patients With Cancer
Gany, F. M., Leng, J. C. F., Ramirez, J., Phillips, S., Aragones, A., Roberts, N. F., Mujawar, M. I., & Costas-Muñíz, R. (2015) · Journal of Oncology Practice · doi:10.1200/jop.2015.003962 · Cited by 58
Zhao, H. P., Liu, Y., Li, H. L., Ma, L., Zhang, Y. J., & Wang, J. (2012) · Quality of Life Research · doi:10.1007/s11136-012-0212-9 · Cited by 58
“First, it has been widely used in cancer patients and verified to have good reliability and validity in breast cancer patients receiving chemotherapy [21, 22].”
BackgroundEPSTEIN, R. A., Heinemann, A. W., & McFarland, L. V. (2010) · The Journal of Rehabilitation Research and Development · doi:10.1682/jrrd.2009.03.0023 · Cited by 58
Cheung, Y. B., Luo, N., Ng, R. C. H., & Lee, C. F. (2014) · Health and Quality of Life Outcomes · doi:10.1186/s12955-014-0180-6 · Cited by 58
“For the BCS subscale, one patient had maximum score at baseline, but none at follow-up.”
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Nyrop, K. A., Deal, A. M., Choi, S. K., Wagoner, C. W., Lee, J.-Y., Wood, A., Anders, C. K., Carey, L., Dees, E. C., Jolly, T. A., et al. (2017) · Breast Cancer Research and Treatment · doi:10.1007/s10549-017-4565-1 · Cited by 58
Guidolin, K., Yaremko, B., Lynn, K., Gaede, S., Kornecki, A., Muscedere, G., Ben-Nachum, I., Shmuilovich, O., Mouawad, M., Yu, E., et al. (2019) · Current Oncology · doi:10.3747/co.26.4479 · Cited by 58
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“[55] (validation of version 3 with two additional items; sample of 295 breast cancer patients) Table 4 Most common problems experienced by sample of breast cancer patients (N = 111)”
BackgroundEffects of Exercise on Biobehavioral Outcomes of Fatigue During Cancer Treatment
Al‐Majid, S., Wilson, L. D., Rakovski, C. S., & Coburn, J. W. (2014) · Biological Research For Nursing · doi:10.1177/1099800414523489 · Cited by 54
Long‐term telephone therapy outcomes for breast cancer patients
Sandgren, A. K., & McCaul, K. D. (2006) · Psycho-Oncology · doi:10.1002/pon.1038 · Cited by 57
“[42] to assess reactions to breast cancer per se (e.”
BackgroundSymptom burden among patients with Renal Cell Carcinoma (RCC): content for a symptom index
Harding, G., Cella, D. F., Robinson, D., Mahadevia, P. J., Clark, J., & Revicki, D. A. (2007) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-5-34 · Cited by 57
Self-citationLee, W. R., McQuellon, R. P., Case, L. D., deGuzman, A. F., & McCullough, D. L. (1999) · The Journal of Urology · doi:10.1016/s0022-5347(05)68570-9 · Cited by 57
A contextual approach to understanding breast cancer survivorship among Latinas
Lopez‐Class, M., Gomez‐Duarte, J., Graves, K. D., & Ashing‐Giwa, K. T. (2011) · Psycho-Oncology · doi:10.1002/pon.1998 · Cited by 56
“Because HRQOL is multifaceted and includes domains related to psychological/emotional, cognitive, functional, spirituality, and physical functioning [4,16], we chose these domains as the starting point of our analysis.”
BackgroundMethodQuality of life in breast cancer patients: Validation of a FACT-B Malayalam version
Pandey, M., Thomas, B. C., Ramdas, K., Eremenco, S. L., & Nair, M. K. (2002) · Quality of Life Research · doi:10.1023/a:1015083713014 · Cited by 56
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“HRQOL The 39-item Functional Assessment of Cancer Therapy-Breast (FACT-B) [38, 39] assessed physical, social/ family, emotional, and functional well-being and breast cancer specific concerns.”
InfluentialPinheiro, L. C., Samuel, C. A., Reeder-Hayes, K. E., Wheeler, S. B., Olshan, A. F., & Reeve, B. B. (2016) · Breast Cancer Research and Treatment · doi:10.1007/s10549-016-3965-y · Cited by 56
“The FACT-B includes 5 domains: Physical Well-Being, Social Well-Being, Emotional Well-Being, Functional Well-Being, and BC-specific Concerns [20].”
InfluentialJesus, S. D., Fitzgeorge, L., Unsworth, K., Massel, D. R., Suskin, N., Harry Prapavessis, A., & Sanatani, M. S. (2017) · Cancer Management and Research · doi:10.2147/cmar.s117703 · Cited by 56
Measuring quality of life in patients with melanoma: development of the FACT-melanoma subscale.
Cormier, J. N., Davidson, L., Xing, Y., Webster, K., & Cella, D. F. (2005) · PubMed · Cited by 56
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“The total scores ranged from 0 to 144, and the higher the score, the better the QOL.”
MethodInfluentialKurosawa, S., Yamaguchi, T., Mori, T., Kanamori, H., Onishi, Y., Emi, N., Fujisawa, S., Kohno, A., Nakaseko, C., Saito, B., et al. (2015) · Bone Marrow Transplantation · doi:10.1038/bmt.2015.137 · Cited by 55
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“The Functional Assessment of Cancer Therapy-Breast (FACT-B) [23] and its Endocrine Symptom Subscale (ES) [24] were used to evaluate HRQOL.”
MethodWells, M., Harrow, A., Donnan, P. T., Davey, P. G., Devereux, S., Little, G., McKenna, E., Wood, R., Chen, R., & Thompson, A. M. (2004) · British Journal of Cancer · doi:10.1038/sj.bjc.6601998 · Cited by 55
“Primary outcomes were quality of life, as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) (Brady et al, 1997) and EQ-5D (Euroqol group, 1990) questionnaires, and carer burden.”
BackgroundMethodInfluentialScreening studies for fatigue and laboratory correlates in cancer patients undergoing treatment.
Shafqat, A., Einhorn, L., Hanna, N. H., Sledge, G., Hanna, A., Juliar, B. E., Monahan, P. O., & Bhatia, S. (2005) · Annals of Oncology · doi:10.1093/annonc/mdi267 · Cited by 56
“FACT-F has been studied much more extensively as a fatigue measurement tool and is comprised of the FACT-General and the FACIT-F scale [20, 21].”
MethodSun, M., Liu, C., Lu, Y., Zhu, F., Li, H., & Lü, Q. (2023) · Asian Nursing Research · doi:10.1016/j.anr.2023.11.001 · Cited by 54
Batenburg, A., & Das, E. H. H. J. (2015) · Journal of Computer-Mediated Communication · doi:10.1111/jcc4.12131 · Cited by 54
“Emotional well-being was measured according six items from the FACT-B (Brady et al., 1997) on a 5-point scale (e.g., “I’m proud of how I am coping with my illness”) and showed scale consistency, Cronbach’s 𝛼 = .86.”
InfluentialCella, D. F. (2004) · Seminars in Oncology · doi:10.1053/j.seminoncol.2004.04.008 · Cited by 54
Self-citationInfluence of irradiation on therapy-associated psychological distress in breast carcinoma patients
Mose, S., Budischewski, K. M., Rahn, A., Zander-Heinz, A., Bormeth, S. B., & Böttcher, H. D. (2001) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/s0360-3016(01)01711-4 · Cited by 54
Health-related quality of life of ICU survivors: review of the literature
Chaboyer, W. P., & Elliott, D. (2000) · Intensive and Critical Care Nursing · doi:10.1054/iccn.1999.1582 · Cited by 54
Quality-of-Life Considerations in the Treatment of Early-Stage Breast Cancer in the Elderly
Reimer, T., & Gerber, B. (2010) · Drugs & Aging · doi:10.2165/11584700-000000000-00000 · Cited by 54
“5 Functional Assessment of Cancer Therapy questionnaires FACT-G;([15]) FACT-B([17])”
InfluentialZamanian, H., Amini‐Tehrani, M., Jalali, Z., Daryaafzoon, M., Ramezani, F., Malek, N., Adabimohazab, M., Hozouri, R., & Taghanaky, F. R. (2022) · Frontiers in Psychology · doi:10.3389/fpsyg.2022.657992 · Cited by 53
Jeste, N. D., Liu, L., Rissling, M. B., Trofimenko, V., Natarajan, L., Parker, B. A., & Ancoli‐Israel, S. (2012) · Quality of Life Research · doi:10.1007/s11136-012-0243-2 · Cited by 53
Risks and Benefits of Physical Activity among Breast Cancer Survivors who have Completed Treatment
Schmitz, K. H., & Speck, R. M. (2010) · Women s Health · doi:10.2217/whe.10.1 · Cited by 57
“The Breast Cancer Subscale of the Functional Assessment of Cancer TherapyBreast (BCS FACT-B) is the only QOL outcome demon strating consistent and statistically significant positive improvement [66].”
BackgroundBelmonte, R., Tejero, M., Ferrer, M., Muniesa, J. M., Duarte, E., Cunillera, O., & Escalada, F. (2011) · Clinical Rehabilitation · doi:10.1177/0269215511427414 · Cited by 53
Eijzenga, W., Hahn, D. E. E., Aaronson, N. K., Kluijt, I., & Bleiker, E. M. A. (2013) · Journal of Genetic Counseling · doi:10.1007/s10897-013-9649-4 · Cited by 53
Pilates for Breast Cancer Survivors
Stan, D. L., Rausch, S. M., Sundt, K., Cheville, A. L., Youdas, J. W., Krause, D. A., Boughey, J. C., Walsh, M. F., Cha, S. S., & Pruthi, S. (2012) · Clinical journal of oncology nursing · doi:10.1188/12.cjon.131-141 · Cited by 61
Physical Activity and Breast Cancer Survivorship
Schmitz, K. H. (2010) · Recent results in cancer research/Recent Results in Cancer Research · doi:10.1007/978-3-642-04231-7_8 · Cited by 53
Ng, R. C. H., Lee, C. F., Wong, N. S., Luo, N., Yap, Y. S., Lo, S. K., Chia, W. K., Yee, A., Krishna, L. K. R., Goh, C. R., et al. (2011) · Breast Cancer Research and Treatment · doi:10.1007/s10549-011-1764-z · Cited by 52
Loh, S. Y., Lee, S. Y., & Murray, L. (2014) · Asian Pacific Journal of Cancer Prevention · doi:10.7314/apjcp.2014.15.19.8127 · Cited by 52
“Masking of treatment allocation were conducted, with ‘matching’ active, placebo and control, using a free online Random Allocation Software (Brady et al., 1997).”
MethodInfluentialVargas, S. E., Wohlgemuth, W. K., Antoni, M. H., Lechner, S. C., Holley, H., & Carver, C. S. (2009) · Psycho-Oncology · doi:10.1002/pon.1603 · Cited by 52
Leach, H. J., Danyluk, J. M., Nishimura, K. C., & Culos-Reed, S. N. (2016) · Supportive Care in Cancer · doi:10.1007/s00520-016-3302-3 · Cited by 58
Tometich, D. B., Small, B. J., Carroll, J., Zhai, W., Luta, G., Zhou, X., Kobayashi, L. C., Ahles, T. A., Saykin, A. J., Clapp, J. D., et al. (2018) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2018.11.015 · Cited by 52
Richard, A., Harbeck, N., Wuerstlein, R., & Wilhelm, F. (2018) · Psycho-Oncology · doi:10.1002/pon.4957 · Cited by 41
Use of tablet personal computers for sensitive patient-reported information.
Dupont, A., Wheeler, J. L., Herndon, J. E., Coan, A., Zafar, S. Y., Hood, L. E., Patwardhan, M. B., Shaw, H. S., Lyerly, H. K., & Abernethy, A. P. (2009) · PubMed · Cited by 52
Stinchcombe, T. E., Roder, J., Peterman, A. H., Grigorieva, J., Lee, C. B., Moore, D. T., & Socinski, M. A. (2013) · Journal of Thoracic Oncology · doi:10.1097/jto.0b013e3182835577 · Cited by 51
Díaz-Balboa, E., Peña, C., Rodríguez‐Romero, B., Cuesta‐Vargas, A., Lado‐Baleato, Ó., Martínez‐Monzonís, A., Pedreira-Pérez, M., Ozores, P. P., López‐López, R., González‐Juanatey, J. R., et al. (2024) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2024.02.002 · Cited by 56
“Although the benefits of exercise on emotional well-being are well established, 44 previous similar studies have failed to show improvements in FACT-B 37 or HADS 35 scores.”
MethodInfluentialPredictive factors for psychological distress related to diagnosis of breast cancer
Iwatani, T., Matsuda, A., Kawabata, H., Miura, D., & Matsushima, E. (2012) · Psycho-Oncology · doi:10.1002/pon.3023 · Cited by 51
“Higher scores on these subscales indicate better meaning/peace and spirituality [26,27].”
BackgroundMultidisciplinary rehabilitation for follow-up of women treated for breast cancer
Khan, F., Amatya, B., Ng, L., Demetrios, M., Zhang, N. Y., & Turner‐Stokes, L. F. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009553.pub2 · Cited by 52
Greenlee, H., Crew, K. D., Shao, T. H., Kranwinkel, G., Kalinsky, K. M., Maurer, M., Brafman, L., Insel, B. J., Tsai, W. Y., & Hershman, D. L. (2012) · Supportive Care in Cancer · doi:10.1007/s00520-012-1628-z · Cited by 51
Lechner, S. C., Whitehead, N. E., Vargas, S. E., Annane, D. W., Robertson, B., Carver, C. S., Kobetz, E. K., & Antoni, M. H. (2014) · JNCI Monographs · doi:10.1093/jncimonographs/lgu032 · Cited by 51
Lyons, E., Baranowski, T., Basen‐Engquist, K., Lewis, Z. H., Swartz, M. C., Jennings, K., & Volpi, E. (2016) · BMC Cancer · doi:10.1186/s12885-016-2244-y · Cited by 55
“Physical (“I have pain”), social (“I feel close to my friends”), functional (“I am able to enjoy life”), emotional (“I feel sad”), and breast-specific (“I am able to feel like a woman”) quality of life will be measured using the 37item Functional Assessment of Cancer Therapy – Breast (FACT-B) measure [77].”
MethodParker, P. A., Peterson, S. K., Shen, Y., Bedrosian, I., Black, D. M., Thompson, A. M., Nelson, J. C., DeSnyder, S. M., Cook, R. L., Hunt, K. K., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2018.78.6442 · Cited by 52
A Cost-effectiveness Analysis of Two Rehabilitation Support Services for Women with Breast Cancer
Gordon, L. G., Scuffham, P., Battistutta, D., Graves, N., Tweeddale, M., & Newman, B. M. (2005) · Breast Cancer Research and Treatment · doi:10.1007/s10549-005-5828-9 · Cited by 51
“The FACT-B+4 change scores generated a dichotomous outcome ‘rehabilitated case’ (yes/no), with ‘rehabilitated case’ defined by improvement in the FACT-B+4 score that reached minimal clinically meaningful difference as recommended by FACT-B developers [22].”
MethodFrechette, D., Paquet, L., Verma, S., Clemons, M. J., Wheatley‐Price, P., Gertler, S. Z., Song, X., Graham, N., & Dent, S. F. (2013) · Breast Cancer Research and Treatment · doi:10.1007/s10549-013-2659-y · Cited by 52
Dance/movement therapy for improving psychological and physical outcomes in cancer patients
Bradt, J., Goodill, S. W., & Dileo, C. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007103.pub2 · Cited by 51
The impact of lung cancer surgery on quality of life trajectories in patients and family caregivers
Kim, J. Y., Sun, V., Raz, D. J., Williams, A. C., Fujinami, R., Reckamp, K., Koczywas, M., Cristea, M., Hurria, A., & Ferrell, B. (2016) · Lung Cancer · doi:10.1016/j.lungcan.2016.08.011 · Cited by 48
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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