Measuring health-related quality of life in patients with hepatobiliary cancers: the functional assessment of cancer therapy-hepatobiliary questionnaire.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Heffernan
Nancy
N
Hepatobiliary Disease Management Program, Memorial Sloan-Kettering Cancer Center, and Beth Israel Medical Center, New York, NY 10021, USA. heffernn@mskcc.org
Cella
David
D
Webster
Kimberly
K
Odom
Linda
L
Martone
Mary
M
Passik
Steven
S
Bookbinder
Marilyn
M
Fong
Yuman
Y
Jarnagin
William
W
Blumgart
Leslie
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001661:Biliary Tract Neoplasms / Q000523:psychology* / Q000628:therapy*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000523:psychology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D012647:Self-Assessment; D011795:Surveys and Questionnaires