Journal of Clinical Oncology, Vol 11, 570-579, Copyright © 1993 by American Society of Clinical Oncology
The Functional Assessment of Cancer Therapy scale: development and validation of the general measure
DF Cella, DS Tulsky, G Gray, B Sarafian, E Linn, A Bonomi, M Silberman, SB Yellen, P Winicour and J Brannon
Rush-Presbyterian-St Luke's Medical Center, Chicago, IL.
PURPOSE: We developed and validated a brief, yet sensitive, 33-item general
cancer quality-of-life (QL) measure for evaluating patients receiving
cancer treatment, called the Functional Assessment of Cancer Therapy (FACT)
scale. METHODS AND RESULTS: The five-phase validation process involved 854
patients with cancer and 15 oncology specialists. The initial pool of 370
overlapping items for breast, lung, and colorectal cancer was generated by
open-ended interview with patients experienced with the symptoms of cancer
and oncology professionals. Using preselected criteria, items were reduced
to a 38-item general version. Factor and scaling analyses of these 38 items
on 545 patients with mixed cancer diagnoses resulted in the 28-item
FACT-general (FACT- G, version 2). In addition to a total score, this
version produces subscale scores for physical, functional, social, and
emotional well- being, as well as satisfaction with the treatment
relationship. Coefficients of reliability and validity were uniformly high.
The scale's ability to discriminate patients on the basis of stage of
disease, performance status rating (PSR), and hospitalization status
supports its sensitivity. It has also demonstrated sensitivity to change
over time. Finally, the validity of measuring separate areas, or
dimensions, of QL was supported by the differential responsiveness of
subscales when applied to groups known to differ along the dimensions of
physical, functional, social, and emotional well-being. CONCLUSION: The
FACT-G meets or exceeds all requirements for use in oncology clinical
trials, including ease of administration, brevity, reliability, validity,
and responsiveness to clinical change. Selecting it for a clinical trial
adds the capability to assess the relative weight of various aspects of QL
from the patient's perspective.

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L. B. Wenzel, H. Q. Huang, D. K. Armstrong, J. L. Walker, and D. Cella
Health-Related Quality of Life During and After Intraperitoneal Versus Intravenous Chemotherapy for Optimally Debulked Ovarian Cancer: A Gynecologic Oncology Group Study
J. Clin. Oncol.,
February 1, 2007;
25(4):
437 - 443.
[Abstract]
[Full Text]
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Y. D. Podnos, G. Juarez, C. Pameijer, K. Choi, B. R. Ferrell, and L. D. Wagman
Impact of Surgical Palliation on Quality of Life in Patients with Advanced Malignancy: Results of the Decisions and Outcomes in Palliative Surgery (DOPS) Trial
Ann. Surg. Oncol.,
February 1, 2007;
14(2):
922 - 928.
[Full Text]
[PDF]
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K. P. Tercyak, B. N. Peshkin, B. M. Brogan, T. DeMarco, M. F. Pennanen, S. C. Willey, C. M. Magnant, S. Rogers, C. Isaacs, and M. D. Schwartz
Quality of Life After Contralateral Prophylactic Mastectomy in Newly Diagnosed High-Risk Breast Cancer Patients Who Underwent BRCA1/2 Gene Testing
J. Clin. Oncol.,
January 20, 2007;
25(3):
285 - 291.
[Abstract]
[Full Text]
[PDF]
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R. J. Motzer, T. E. Hutson, P. Tomczak, M. D. Michaelson, R. M. Bukowski, O. Rixe, S. Oudard, S. Negrier, C. Szczylik, S. T. Kim, et al.
Sunitinib versus Interferon Alfa in Metastatic Renal-Cell Carcinoma
N. Engl. J. Med.,
January 11, 2007;
356(2):
115 - 124.
[Abstract]
[Full Text]
[PDF]
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T. D. Shanafelt and N. E. Kay
Comprehensive Management of the CLL Patient: A Holistic Approach
Hematology,
January 1, 2007;
2007(1):
324 - 331.
[Abstract]
[Full Text]
[PDF]
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B. Kelly, S. McClement, and H. M. Chochinov
Measurement of psychological distress in palliative care
Palliative Medicine,
December 1, 2006;
20(8):
779 - 789.
[Abstract]
[PDF]
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T. M. Tuttle, Y. Zhang, E. Greeno, and A. Knutsen
Toxicity and Quality of Life after Cytoreductive Surgery Plus Hyperthermic Intraperitoneal Chemotherapy
Ann. Surg. Oncol.,
December 1, 2006;
13(12):
1627 - 1632.
[Abstract]
[Full Text]
[PDF]
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P. J. Stiff, C. Emmanouilides, W. I. Bensinger, T. Gentile, B. Blazar, T. C. Shea, J. Lu, J. Isitt, A. Cesano, and R. Spielberger
Palifermin Reduces Patient-Reported Mouth and Throat Soreness and Improves Patient Functioning in the Hematopoietic Stem-Cell Transplantation Setting
J. Clin. Oncol.,
November 20, 2006;
24(33):
5186 - 5193.
[Abstract]
[Full Text]
[PDF]
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L. A. Simmons, S. C. Modesitt, A. C. Brody, and A. B. Leggin
Food Insecurity Among Cancer Patients in Kentucky: A Pilot Study
J. Oncol. Pract,
November 1, 2006;
2(6):
274 - 279.
[Abstract]
[Full Text]
[PDF]
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E. Kikuchi, Y. Horiguchi, J. Nakashima, T. Ohigashi, M. Oya, K. Nakagawa, A. Miyajima, and M. Murai
Assessment of Long-Term Quality of Life Using the FACT-BL Questionnaire in Patients with an Ileal Conduit, Continent Reservoir, or Orthotopic Neobladder
Jpn. J. Clin. Oncol.,
November 1, 2006;
36(11):
712 - 716.
[Abstract]
[Full Text]
[PDF]
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M. J. Clemons, G. Dranitsaris, W. S. Ooi, G. Yogendran, T. Sukovic, B. Y.L. Wong, S. Verma, K. I. Pritchard, M. Trudeau, and D. E.C. Cole
Phase II Trial Evaluating the Palliative Benefit of Second-Line Zoledronic Acid in Breast Cancer Patients With Either a Skeletal-Related Event or Progressive Bone Metastases Despite First-Line Bisphosphonate Therapy
J. Clin. Oncol.,
October 20, 2006;
24(30):
4895 - 4900.
[Abstract]
[Full Text]
[PDF]
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A S. Pickard and S.-Y. Hung
An Update on Evidence of Clinical Pharmacy Services' Impact on Health-Related Quality of Life
Ann. Pharmacother.,
September 1, 2006;
40(9):
1623 - 1634.
[Abstract]
[Full Text]
[PDF]
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S Basu and N Nair
Stable disease and improved health-related quality of life (HRQoL) following fractionated low dose 131I-metaiodobenzylguanidine (MIBG) therapy in metastatic paediatric paraganglioma: observation on false "reverse" discordance during pre-therapy work up and its implication for patient selection for high dose targeted therapy
Br. J. Radiol.,
August 1, 2006;
79(944):
e53 - e58.
[Abstract]
[Full Text]
[PDF]
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E. E.W. Cohen, D. J. Haraf, M. A. List, M. Kocherginsky, B. B. Mittal, F. Rosen, B. Brockstein, R. Williams, M. E. Witt, K. M. Stenson, et al.
High Survival and Organ Function Rates After Primary Chemoradiotherapy for Intermediate-Stage Squamous Cell Carcinoma of the Head and Neck Treated in a Multicenter Phase II Trial
J. Clin. Oncol.,
July 20, 2006;
24(21):
3438 - 3444.
[Abstract]
[Full Text]
[PDF]
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E. A Hahn, R. K Bode, H. Du, and D. Cella
Evaluating linguistic equivalence of patient-reported outcomes in a cancer clinical trial
Clinical Trials,
June 1, 2006;
3(3):
280 - 290.
[Abstract]
[PDF]
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E. Bruera, V. Valero, L. Driver, L. Shen, J. Willey, T. Zhang, and J. L. Palmer
Patient-Controlled Methylphenidate for Cancer Fatigue: A Double-Blind, Randomized, Placebo-Controlled Trial
J. Clin. Oncol.,
May 1, 2006;
24(13):
2073 - 2078.
[Abstract]
[Full Text]
[PDF]
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J. Kirkova, M. P. Davis, D. Walsh, E. Tiernan, N. O'Leary, S. B. LeGrand, R. L. Lagman, and K. M. Russell
Cancer Symptom Assessment Instruments: A Systematic Review
J. Clin. Oncol.,
March 20, 2006;
24(9):
1459 - 1473.
[Abstract]
[Full Text]
[PDF]
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D. Khuntia, P. Brown, J. Li, and M. P. Mehta
Whole-Brain Radiotherapy in the Management of Brain Metastasis
J. Clin. Oncol.,
March 10, 2006;
24(8):
1295 - 1304.
[Abstract]
[Full Text]
[PDF]
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D. G. Pfister, Y. B. Su, D. H. Kraus, S. L. Wolden, E. Lis, T. B. Aliff, A. J. Zahalsky, S. Lake, M. N. Needle, A. R. Shaha, et al.
Concurrent Cetuximab, Cisplatin, and Concomitant Boost Radiotherapy for Locoregionally Advanced, Squamous Cell Head and Neck Cancer: A Pilot Phase II Study of a New Combined-Modality Paradigm
J. Clin. Oncol.,
March 1, 2006;
24(7):
1072 - 1078.
[Abstract]
[Full Text]
[PDF]
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H. Ishikawa, T. Saeki, T. Otani, T. Suzuki, K. Shimozuma, H. Nishino, S. Fukuda, and K. Morimoto
Aged Garlic Extract Prevents a Decline of NK Cell Number and Activity in Patients with Advanced Cancer
J. Nutr.,
March 1, 2006;
136(3):
816S - 820S.
[Abstract]
[Full Text]
[PDF]
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S. Burdette-Radoux and H. B. Muss
Adjuvant chemotherapy in the elderly: whom to treat, what regimen?
Oncologist,
March 1, 2006;
11(3):
234 - 242.
[Abstract]
[Full Text]
[PDF]
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D. Dubois, R. Dhawan, H. van de Velde, D. Esseltine, S. Gupta, M. Viala, and C. de la Loge
Descriptive and Prognostic Value of Patient-Reported Outcomes: The Bortezomib Experience in Relapsed and Refractory Multiple Myeloma
J. Clin. Oncol.,
February 20, 2006;
24(6):
976 - 982.
[Abstract]
[Full Text]
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J. L. Steel, D. T. Eton, D. Cella, M. C. Olek, and B. I. Carr
Clinically meaningful changes in health-related quality of life in patients diagnosed with hepatobiliary carcinoma
Ann. Onc.,
February 1, 2006;
17(2):
304 - 312.
[Abstract]
[Full Text]
[PDF]
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K. E. Steinhauser, C. I. Voils, E. C. Clipp, H. B. Bosworth, N. A. Christakis, and J. A. Tulsky
"Are You at Peace?": One Item to Probe Spiritual Concerns at the End of Life
Arch Intern Med,
January 9, 2006;
166(1):
101 - 105.
[Abstract]
[Full Text]
[PDF]
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M. A. Socinski, A. Ivanova, K. Bakri, J. Wall, M. Q. Baggstrom, T. A. Hensing, A. Mears, M. Tynan, J. Beaumont, A. H. Peterman, et al.
A randomized phase II trial comparing every 3-weeks carboplatin/paclitaxel with every 3-weeks carboplatin and weekly paclitaxel in advanced non-small cell lung cancer
Ann. Onc.,
January 1, 2006;
17(1):
104 - 109.
[Abstract]
[Full Text]
[PDF]
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M. A. Lieberman and B. A. Goldstein
Self-help On-line: An Outcome Evaluation of Breast Cancer Bulletin Boards
J Health Psychol,
December 1, 2005;
10(6):
855 - 862.
[Abstract]
[PDF]
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E. E.W. Cohen, M. A. Kane, M. A. List, B. E. Brockstein, B. Mehrotra, D. Huo, A. M. Mauer, C. Pierce, A. Dekker, and E. E. Vokes
Phase II Trial of Gefitinib 250 mg Daily in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Clin. Cancer Res.,
December 1, 2005;
11(23):
8418 - 8424.
[Abstract]
[Full Text]
[PDF]
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H. G. M. Fan, N. Houede-Tchen, Q.-L. Yi, I. Chemerynsky, F. P. Downie, K. Sabate, and I. F. Tannock
Fatigue, Menopausal Symptoms, and Cognitive Function in Women After Adjuvant Chemotherapy for Breast Cancer: 1- and 2-Year Follow-Up of a Prospective Controlled Study
J. Clin. Oncol.,
November 1, 2005;
23(31):
8025 - 8032.
[Abstract]
[Full Text]
[PDF]
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E. S. Costanzo, S. K. Lutgendorf, S. L. Bradley, S. L. Rose, and B. Anderson
Cancer Attributions, Distress, and Health Practices Among Gynecologic Cancer Survivors
Psychosom Med,
November 1, 2005;
67(6):
972 - 980.
[Abstract]
[Full Text]
[PDF]
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A. Shafqat, L. H. Einhorn, N. Hanna, G. W. Sledge, A. Hanna, B. E. Juliar, P. Monahan, and S. Bhatia
Screening studies for fatigue and laboratory correlates in cancer patients undergoing treatment{dagger}
Ann. Onc.,
September 1, 2005;
16(9):
1545 - 1550.
[Abstract]
[Full Text]
[PDF]
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L. Wenzel, H. Q. Huang, B. J. Monk, P. G. Rose, and D. Cella
Quality-of-Life Comparisons in a Randomized Trial of Interval Secondary Cytoreduction in Advanced Ovarian Carcinoma: A Gynecologic Oncology Group Study
J. Clin. Oncol.,
August 20, 2005;
23(24):
5605 - 5612.
[Abstract]
[Full Text]
[PDF]
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R. S. Herbst, M. Arquette, D. M. Shin, K. Dicke, E. E. Vokes, N. Azarnia, W. K. Hong, and M. S. Kies
Phase II Multicenter Study of the Epidermal Growth Factor Receptor Antibody Cetuximab and Cisplatin for Recurrent and Refractory Squamous Cell Carcinoma of the Head and Neck
J. Clin. Oncol.,
August 20, 2005;
23(24):
5578 - 5587.
[Abstract]
[Full Text]
[PDF]
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Y.-B. Cheung, C. Goh, J. Thumboo, K.-S. Khoo, and J. Wee
Variability and Sample Size Requirements of Quality-of-Life Measures: A Randomized Study of Three Major Questionnaires
J. Clin. Oncol.,
August 1, 2005;
23(22):
4936 - 4944.
[Abstract]
[Full Text]
[PDF]
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B. J. Monk, H. Q. Huang, D. Cella, and H. J. Long III
Quality of Life Outcomes From a Randomized Phase III Trial of Cisplatin With or Without Topotecan in Advanced Carcinoma of the Cervix: A Gynecologic Oncology Group Study
J. Clin. Oncol.,
July 20, 2005;
23(21):
4617 - 4625.
[Abstract]
[Full Text]
[PDF]
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