This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Heffernan, N. Articles by Blumgart, L. Search for Related Content PubMed PubMed Citation Articles by Heffernan, N. Articles by Blumgart, L.

Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy–Hepatobiliary Questionnaire

From the Hepatobiliary Disease Management Program, Memorial Sloan-Kettering Cancer Center, and Beth Israel Medical Center, New York, and Jacobi Medical Center, Bronx, NY; Evanston Northwestern Healthcare and Northwestern University, Evanston, IL; and Community Cancer Care, Indianapolis, IN.

Address reprint requests to Nancy Heffernan, RN, BSN, Hepatobiliary Disease Management Program, Memorial Sloan-Kettering Cancer Center, Hepatobiliary Service Box 549, New York, NY 10021; email: heffernn{at}mskcc.org

PURPOSE: This is the first report on the development and initial validation of the Functional Assessment of Cancer Therapy–Hepatobiliary (FACT-Hep) questionnaire, a 45-item self-report instrument designed to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers. The FACT-Hep consists of the 27-item FACT-G, which assesses generic HRQL concerns, and the newly validated 18-item Hepatobiliary Subscale (HS), which assesses disease-specific issues.

PATIENTS AND METHODS: The development of the HS followed a four-phase process of item generation, item reduction, scale construction, and reliability/validity testing. Two independent samples were studied: item generation (sample 1; n = 30) and reliability/validity testing (sample 2; n = 51).

RESULTS: In sample 2, all subscales and aggregated scores showed high internal consistency at initial assessment (Cronbach’s alpha range, 0.72 to 0.94) and retesting (Cronbach’s alpha range, 0.81 to 0.94). Measurement stability over a 3- to 7-day period was also high for all aggregated scales (test-retest correlation range, 0.84 to 0.91; intraclass correlation coefficient range, 0.82 to 0.90). Convergent and divergent validity were demonstrated by examining relationships between FACT subscales and mood, social support, and social desirability. Finally, when performance status and treatment status were used to divide sample 2, the HS differentiated groups to a degree comparable to the Physical and Functional Well-Being subscales of the FACT-G, thereby contributing favorably to a 32-item Trial Outcome Index. In addition to the 18 validated, scored items in the HS, seven treatment-related items may be appended, if clinically indicated, as a separate subscale.

CONCLUSION: The 45-item FACT-Hep can be used independently as a brief measure of disease-related symptoms and functioning. Alone or paired with the FACT-G, the HS has promise for use in assessing the disease-specific HRQL of patients with hepatobiliary cancers.

This article has been cited by other articles:

				J. M. Llovet, A. M. Di Bisceglie, J. Bruix, B. S. Kramer, R. Lencioni, A. X. Zhu, M. Sherman, M. Schwartz, M. Lotze, J. Talwalkar, et al. Design and Endpoints of Clinical Trials in Hepatocellular Carcinoma J Natl Cancer Inst, May 21, 2008; 100(10): 698 - 711. [Abstract] [Full Text] [PDF]

				J. M. Blazeby, K. Avery, M. Sprangers, H. Pikhart, P. Fayers, and J. Donovan Health-Related Quality of Life Measurement in Randomized Clinical Trials in Surgical Oncology J. Clin. Oncol., July 1, 2006; 24(19): 3178 - 3186. [Abstract] [Full Text] [PDF]

				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]

				S. L. Eremenco, D. Cella, and B. J. Arnold A Comprehensive Method for the Translation and Cross-Cultural Validation of Health Status Questionnaires Eval Health Prof, June 1, 2005; 28(2): 212 - 232. [Abstract] [PDF]

				M.-F. Demierre, A. Tien, and D. Miller Health-Related Quality-of-Life Assessment in Patients With Cutaneous T-Cell Lymphoma Arch Dermatol, March 1, 2005; 141(3): 325 - 330. [Abstract] [Full Text] [PDF]

				C. M. Rocha Lima, M. R. Green, R. Rotche, W. H. Miller Jr, G. M. Jeffrey, L. A. Cisar, A. Morganti, N. Orlando, G. Gruia, and L. L. Miller Irinotecan Plus Gemcitabine Results in No Survival Advantage Compared With Gemcitabine Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer Despite Increased Tumor Response Rate J. Clin. Oncol., September 15, 2004; 22(18): 3776 - 3783. [Abstract] [Full Text] [PDF]

				M. N. Levine and P. A. Ganz Beyond the Development of Quality-of-Life Instruments: Where Do We Go From Here? J. Clin. Oncol., May 1, 2002; 20(9): 2215 - 2216. [Full Text] [PDF]