nach oben

Quality of Life Research

Erschienen in:

01.06.2013

Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer

verfasst von: David Cella, Zeeshan Butt, Hedy Lee Kindler, Charles S. Fuchs, Sarah Bray, Arie Barlev, Alan Oglesby

Erschienen in: Quality of Life Research | Ausgabe 5/2013

Einloggen, um Zugang zu erhalten

Abstract

Purpose

Evaluate reliability and validity of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire and its derivative FACT Hepatobiliary Symptom Indexes (FHSI-18 and FHSI-8) in people with metastatic pancreatic cancer.

Methods

Self-reported questionnaire data from a randomized controlled Phase II study evaluating the efficacy and safety of conatumumab (AMG 655), ganitumab (AMG 479) or placebo combined with gemcitabine were evaluated. The following were assessed: internal consistency, using Cronbach’s α; discriminant validity, comparing baseline patient-reported outcomes (PRO) scores across Eastern Cooperative Oncology Group (ECOG) performance status (PS) levels; and ability to detect change, comparing change from baseline PRO score at each cycle across PS and tumour response groups.

Results

The analysis included 96 patients. All scale scores demonstrated good internal consistency (Cronbach’s α > 0.7) and discriminant validity. Baseline scores were significantly poorer among patients with PS = 1 versus patients with PS = 0 (e.g. difference in FACT-Hep total score −17.27; p < 0.001). Ability to detect change was established for Cycles 2/3 versus baseline; PRO scores reduced in the PS-worsened group versus the PS-stable group (e.g. difference in FACT-Hep total score −24.29; p < 0.001). All PRO scale scores showed significant decline for progressive disease versus stable disease (e.g. difference in FACT-Hep total score −12.58; p = 0.004). Changes on the FHSI-18 and FHSI-8 scales were similar in magnitude whether ECOG improved or worsened.

Conclusions

FACT-Hep detects change and is a reliable and valid instrument for measuring health-related quality of life in patients with metastatic pancreatic cancer.

Ferlay, J., Autier, P., Boniol, M., Heanue, M., Colombet, M., & Boyle, P. (2007). Estimates of the cancer incidence and mortality in Europe in (2006). Annals of Oncology, 18(3), 581–592.PubMedCrossRef

Lockhart, A. C., Rothenberg, M. L., & Berlin, J. D. (2005). Treatment for pancreatic cancer: Current therapy and continued progress. Gastroenterology, 128(6), 1642–1654.PubMedCrossRef

Bayraktar, S., & Rocha-Lima, C. M. (2010). Advanced or metastatic pancreatic cancer: Molecular targeted therapies. The Mount Sinai Journal of Medicine, New York, 77(6), 606–619.PubMedCrossRef

Moore, M. J., Goldstein, D., Hamm, J., Figer, A., Hecht, J. R., Gallinger, S., et al. (2007). Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: A Phase III trial of the National Cancer Institute of Canada Clinical Trials Group. Journal of Clinical Oncology, 25(15), 1960–1966.PubMedCrossRef

Fitzsimmons, D., & Johnson, C. D. (1998). Quality of life after treatment of pancreatic cancer. Langenbeck’s Archives of Surgery, 383(2), 145–151.PubMedCrossRef

Fitzsimmons, D., Johnson, C. D., George, S., Payne, S., Sandberg, A. A., Bassi, C., et al. (1999). Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer. EORTC Study Group on Quality of Life. European Journal of Cancer, 35(6), 939–941.PubMedCrossRef

Heffernan, N., Cella, D., Webster, K., Odom, L., Martone, M., Passik, S., et al. (2002). Measuring health-related quality of life in patients with hepatobiliary cancers: The functional assessment of cancer therapy—hepatobiliary questionnaire. Journal of Clinical Oncology, 20(9), 2229–2239.PubMedCrossRef

Cella, D. F., Tulsky, D. S., Gray, G., et al. (1993). The functional assessment of cancer therapy scale: Development and validation of the general measure. Journal of Clinical Oncology, 11(3), 570–579.PubMed

Cella, D., Webster, K., Chang, C. H., Sarafian, B., Linn, E., Bonomi, A., et al. (2000) Deriving a clinically meaningful symptom index from the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) scale: The FHSI-8. Quality of Life Research, 9(3), 293 (Abstract #1591).

10.

Yount, S., Cella, D., Webster, K., Heffernan, N., Chang, C., Odom, L., et al. (2002). Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: The FACT Hepatobiliary Symptom Index. Journal of Pain and Symptom Management, 24(1), 32–44.PubMedCrossRef

11.

Cella, D., Rosenbloom, S. K., Beaumont, J. L., Yount, S. E., Paul, D., Hampton, D., et al. (2011). Development and validation of 11 symptom indexes to evaluate response to chemotherapy for advanced cancer. Journal of the National Comprehensive Cancer Network, 9(3), 268–278.PubMed

12.

Yost, K. J., & Eton, D. T. (2005). Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Evaluations & The Health Professions, 28(2), 172–191.CrossRef

13.

Kindler, H. L., Richards, D. A., Stephenson, J., Garbo, L. E., Rocha Lima, H., Safran, J. S., et al. (2010) A placebo-controlled, randomized phase II study of conatumumab (C) or AMG 479 (A) or placebo (P) plus gemcitabine (G) in patients (pts) with metastatic pancreatic cancer (mPC). Journal of Clinical Oncology, 28(15 suppl), abstract 4035.

14.

Cella, D. (1997). Manual of the functional assessment of chronic illness therapy (FACIT) measurement system. Center on Outcomes, Research and Education (CORE), Evanston Northwestern Healthcare and Northwestern University, Evanston IL, Version 4. www.facit.org.

15.

Webster, K., Cella, D., & Yost, K. (2003). The functional assessment of chronic illness therapy (FACIT) measurement system: Properties applications, and interpretation. Health and Quality of Life Outcomes, 1, 79.PubMedCrossRef

16.

Cella, D. (1994). The manual of the functional assessment of cancer therapy (FACT) measurement system (version 3). Chicago, IL, Rush- Presbyterian-St. Luke’s Medical Center, Rush University.

17.

Functional Assessment of Chronic Illness Therapy [FACIT] measurement system www.facit.org/FACITOrg/Questionnaires.

18.

Scientific Advisory Committee of the Medical Outcomes Trust. (2002). Assessing health status and quality-of-life instruments: Attributes and review criteria. Quality of Life Research, 11(3), 193–205.CrossRef

19.

Guyatt, G., Walter, S., & Norman, G. (1987). Measuring change over time: Assessing the usefulness of evaluative instruments. Journal of Chronic Diseases, 40(2), 171–178.PubMedCrossRef

20.

Colwell, H. H., Mathias, S. D., Turner, M. P., Lu, J., Wright, N., Peeters, M., et al. (2010). Psychometric evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness. The Oncologist, 15(3), 308–316.PubMedCrossRef

21.

Cella, D., Hahn, E., & Dineen, K. (2002). Meaningful change in cancer-specific quality of life scores: Differences between improvement and worsening. Quality of Life Research, 11(3), 207–221.PubMedCrossRef

22.

Ringash, J., & Bezjak, A. (2001). A structured review of quality of life instruments for head and neck cancer patients. Head and Neck, 23(3), 201–213.PubMedCrossRef

23.

Lai, J. S., Beaumont, J. L., Ogale, S., Brunetta, P., & Cella, D. (2011). Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial. Journal of Rheumatology, 38(4), 672–679.PubMedCrossRef

Titel: Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer
verfasst von: David Cella
Zeeshan Butt
Hedy Lee Kindler
Charles S. Fuchs
Sarah Bray
Arie Barlev
Alan Oglesby
Publikationsdatum: 01.06.2013
Verlag: Springer Netherlands
Erschienen in: Quality of Life Research / Ausgabe 5/2013
Print ISSN: 0962-9343
Elektronische ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-012-0217-4

Springer Medizin

Abstract

Purpose

Methods

Results

Conclusions

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 5/2013

Favorable effects of explanatory illustrations attached to a self-administered questionnaire for upper extremity disorders

Introducing the WHOQOL-SRPB BREF: developing a short-form instrument for assessing spiritual, religious and personal beliefs within quality of life

Adaptation into Spanish of the Warwick–Edinburgh Mental Well-being Scale (WEMWBS) and preliminary validation in a student sample

The Hearing Handicap Inventory for Elderly-Screening (HHIE-S) versus a single question: reliability, validity, and relations with quality of life measures in the elderly community, Japan

Discriminant and convergent validity of a subjective quality-of-life instrument aimed at high content validity for schizophrenic persons

Visual analogue scales: scale recalibration by patients with dementia and their proxies