Abstract
The classical criteria for the evaluation of clinical trials in cancer reflect alterations in physical well-being, but are insensitive to other important factors, such as psychosocial state, sociability, and somatic sensation that may play a critical role in determining the patients' functional response to their illness and its treatment. The Functional Living Index-Cancer is designed for easy, repeated patient self-administration. It is a 22-item questionnaire that has been validated on 837 patients in two cities over a three-year period. Criteria for validity include stability of factor analysis, concurrent validation studies against the Karnofsky, Beck Depression, Spielberger State and Trait Anxiety, and Katz Activities of Daily Living scales, as well as the scaled version of The General Health Questionnaire and The McGill/ Melzack Pain Index. The index is uncontaminated by social desirability issues. The validation studies demonstrate the lack of correlation between traditional measures of patient response and other significant functional factors such as depression and anxiety (r = 0.33), sociability and family interaction, and nausea. These findings elucidate the frequently observed discrepancies between traditional assessments of clinical response and overall functional patient outcome. The index is proposed as an adjunct to clinical trials assessment and may provide additional patient functional information on which to analyse the outcome of clinical trials or offer specific advice to individual patients.
Keywords
Affiliated Institutions
Related Publications
The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in Oncology
These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to...
Analysis of Clinical Methods Used to Evaluate Dyspnea in Patients with Chronic Obstructive Pulmonary Disease
When dyspnea must be assessed clinically, there are three methods of assessment: the measurement of dyspnea with activities of daily living using clinical dyspnea ratings such a...
Depression in Patients With Lung Cancer: Prevalence and Risk Factors Derived From Quality-of-Life Data
PURPOSE: To evaluate self-reported depression rates in patients with inoperable lung cancer and to explore demographic, clinical, and quality-of-life (QOL) factors associated wi...
Efficacy and Safety of Agomelatine in the Treatment of Major Depressive Disorder
In this 8-week double-blind multicenter trial, we evaluated the efficacy and safety of 2 fixed doses of agomelatine in patients with moderate to severe major depressive disorder...
Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes
HEALTH-related quality of life (HRQL) is increasingly used as an outcome in clinical trials, effectiveness research, and research on quality of care. Factors that have facilitat...
Publication Info
- Year
- 1984
- Type
- article
- Volume
- 2
- Issue
- 5
- Pages
- 472-483
- Citations
- 1049
- Access
- Closed
External Links
Social Impact
Social media, news, blog, policy document mentions
Citation Metrics
Cite This
Identifiers
- DOI
- 10.1200/jco.1984.2.5.472