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Query: UMLS:C0684249 (lung carcinoma)
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The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.
Lung Cancer 1995 Jun
PMID:Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. 765 30

This review compares the key features and psychometric properties of three site-specific quality of life measures that are currently being used in clinical trials for new therapeutic agents for lung cancer. These measures include the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and its lung cancer module (EORTC-QLQ-LC13), the Functional Assessment of Cancer Therapy--Lung Cancer Quality of Life Instrument (FACT-L), and the Lung Cancer Symptom Scale (LCSS). Differences are found among the three instruments. However, these differences allow choice of detail concerning specific aspects of quality of life, depending on the purpose of the assessment. All three instruments have acceptable feasibility. The FACT-L and LCSS are also reliable measures for lung cancer patients, but the EORTC lung cancer module needs refinement of its pain subscale and further testing of reliability. Additionally, all three instruments have support for validity, with the LCSS and EORTC lung cancer modules having had more extensive testing, and having been tested with larger samples than the FACT-L. The EORTC and FACT are still under development; thus, each will need further testing. The LCSS has fewer questionable psychometric properties than the other two measures, and the development of items is complete. For repeated measures with patients with the progressive disease of lung cancer, the LCSS provides less patient and staff burden with its nine-item patient and six-item observer scales. Both the EORTC lung cancer module and FACT-L are measures that expect the core measure to be administered, requiring 40+ items each. Alternatively, the EORTC and the FACT, including their site-specific modules, provide a more comprehensive assessment than the LCSS, if that is the intent of the quality of life assessment.
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PMID:Comparison of instruments for measuring quality of life in patients with lung cancer. 861 Feb 35

The quality of life of lung cancer patients is affected by several factors related to the patients, stage of disease and treatment characteristics. For small-cell lung cancer (SCLC), the treatment is generally aggressive, primarily based on chemotherapy. Treatment strategy for non-small-cell lung cancer (NSCLC) is strongly dependent on the stage of the disease and ranges from surgery to palliative chemotherapy. Over the last few years, very little progress has been made in terms of survival. Therefore, the effect of treatment on quality of life has become progressively more relevant. Among the instruments for measuring quality of life, there are some specifically developed for lung cancer, such as the European Organization for Research and Treatment of Cancer (EORTC) LC-13 questionnaire, the Functional Assessment of Cancer Therapy (FACT-L) questionnaire and the Lung Cancer Symptom Scale (LCSS). Up to now, few randomised clinical trials have correctly evaluated quality of life. There are evident pitfalls associated with the use of frequently non-validated tools, and poor methods of data analysis, but quality-of-life evaluation is crucial and should be addressed through well-planned and well-conducted prospective clinical trials.
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PMID:Quality of life in lung cancer patients. 1180 79

To assess the impact of disease and treatment on patients with advanced non-small cell lung cancer (NSCLC), we set out to determine a clinically meaningful change (CMC) on the Lung Cancer Subscale (LCS) and the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. We used data from Eastern Cooperative Oncology Group study 5592 (E5592), a randomized trial comparing three chemotherapeutic regimens in 599 advanced NSCLC patients. Patients completed the FACT-L at baseline (pretreatment), 6 weeks, 12 weeks, and 6 months. Comparing across baseline performance status (0 vs. 1), prior weight loss (<5% vs. > or = 5%), and primary disease symptoms (< or = 1 vs. >1), LCS and TOI score differences ranged from 2.4 to 3.6 and 6.5 to 9.2, respectively (all Ps <.001). Mean improvement in LCS score from baseline to 12 weeks was 2.4 points in patients who had responded to treatment versus 0.0 points in patients who had progressive disease. Twelve-week LCS change scores for patients progressing early were 3.1 points worse than those of patients progressing later (mean = -1.2 vs.1.9, respectively). Similarly, the average TOI change score from baseline to 12 weeks was -6.1 for patients who had progressive disease versus -0.8 points for patients who had responded to treatment. Twelve-week TOI change scores for patients progressing early (mean = -8.1) were 5.7 points worse than those of patients progressing later (mean = -8.1 vs. -2.4, respectively). Analyses assuming nonrandom missing data resulted in slightly larger differences. Clinically relevant change scores were estimated as two to three points for the LCS and five to seven points for the TOI, setting upper limits for minimal CMCs. These values were comparable to suggested distribution-based criteria of a minimally important difference. These results support use of a two to three point change in the LCS and five to six point change on the TOI of the FACT-L as a CMC, and offer practical direction for inclusion of important patient-based endpoints in lung cancer clinical trials.
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PMID:What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. 1186

The majority of patients with non-small cell lung cancer (NSCLC) present with advanced disease, which is associated with a poor prognosis and symptoms such as pain, coughing, and shortness of breath. In patients who present at an earlier stage, the progressive nature of NSCLC and its resistance to treatment often result in recurrence, with the associated symptoms of advanced disease. These symptoms negatively affect patient quality of life and performance status rating, both of which are predictive of treatment response and survival. There is increasing interest in using assessments of improvements in symptoms and quality of life as outcomes in clinical trials for patients with advanced NSCLC. Patients with NSCLC have limited therapeutic options. Even those patients who are able to tolerate chemotherapy can expect median survival increases of only 2 to 4 months. The new targeted therapies for lung cancer, in contrast, are relatively nontoxic and may provide benefits for symptoms and quality of life in addition to tumor responses. The Functional Assessment of Cancer Therapy-Lung (FACT-L) scale is a validated, sensitive, and reliable patient questionnaire that evaluates and quantifies quality of life across several dimensions, including lung cancer-related symptoms (Lung Cancer Subscale). The Lung Cancer Subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). A change of two points reflects a clinically significant change in NSCLC-related symptoms and quality of life. In phase I studies and also in the Iressa Dose Evaluation in Advanced Lung Cancer (IDEAL)-1 and IDEAL-2 phase II monotherapy trials, treatment of patients with advanced NSCLC with the epidermal growth factor receptor-tyrosine kinase inhibitor ZD1839 (Iressa; AstraZeneca Pharmaceuticals LP, Wilmington, DE) has shown tumor responses as well as rapid improvements in NSCLC-related symptoms and quality of life. In IDEAL-1 and IDEAL-2, improvements in NSCLC-related symptoms and quality of life, as measured by FACT-L, correlated with tumor response, and improvements in symptoms also correlated with progression-free and overall survival. Although symptom response is correlated with tumor response, it is also uniquely predictive of progression-free and overall survival. The FACT-L questionnaire has also been included in phase III trials of ZD1839 treatment in combination with chemotherapy regimens.
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PMID:Impact of ZD1839 on non-small cell lung cancer-related symptoms as measured by the functional assessment of cancer therapy-lung scale. 1264 83

In the management of advanced non-small-cell lung cancer (NSCLC), quality of life (QOL) is a very important consideration when determining therapy. However, clinicians and patients generally make their treatment decisions based upon informal appraisal of QOL rather than formal assessment. Previously, we showed that Functional Assessment of Cancer Therapy-Lung (FACT-L) data were highly prognostic of survival in advanced NSCLC, suggesting the potential value of FACT-L scores for treatment decision making. A key barrier is the impracticality and burden of real-time administration and scoring of paper forms in the clinic. Handheld and touch screen computer administration and scoring can address that barrier. This pilot study assessed the feasibility of using computer technology to aid in the collection and interpretation of QOL and selected clinical data in real time, reducing human effort. The technology was found to be acceptable to patients and staff and feasible within the clinical setting. Integrating formal QOL assessment into treatment decision making in a clinical oncology setting requires further evaluation.
Clin Lung Cancer 2002 Sep
PMID:Real-time clinical application of quality-of-life assessment in advanced lung cancer. 1465 67

PURPOSE Evaluation of disease-related symptom improvement rate by the Lung Cancer Subscale (LCS) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire was a coprimary end point of the pivotal phase II trial of gefitinib (Iressa; AstraZeneca, Wilmington, DE) conducted in the United States. This report includes the results of analyses exploring the relationship between weekly LCS scores and radiographic response and survival, as well as detailed protocol-specified analysis of symptom and quality-of-life data. PATIENTS AND METHODS In this trial, 216 symptomatic patients with advanced non-small-cell lung cancer (NSCLC) who had at least two prior chemotherapy regimens received gefitinib 250 or 500 mg/d. Disease-related symptoms were assessed weekly and quality of life was assessed monthly by LCS and FACT-L, respectively. Results Symptom improvement was rapid and correlated with tumor response and survival. At the recommended gefitinib dose of 250 mg/d, median overall survival times were 13.6 and 4.6 months for patients with and without symptom improvement, respectively, and 9.7 months for patients with symptom improvement without tumor response. Among patients with stable disease or disease progression, those with symptom improvement had significantly better overall survival than those without improvement. At 250 mg/d, 30% of patients showed a quality-of-life improvement that was correlated with tumor response. CONCLUSION This triadic analysis of response, survival, and symptom data supports the hypothesis that tumor response and symptom response are related and that each predicts survival. Among these NSCLC patients treated with gefitinib, symptom improvement was complementary to and, for most patients, preceded evidence of radiographic regression.
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PMID:Clinically meaningful improvement in symptoms and quality of life for patients with non-small-cell lung cancer receiving gefitinib in a randomized controlled trial. 1569 77

Our objective was to evaluate gefitinib (IRESSA), an epidermal growth factor receptor tyrosine kinase inhibitor, versus docetaxel as second-line monotherapy for advanced non-small-cell lung cancer (NSCLC). SIGN (Second-line Indication of Gefitinib in NSCLC; code 1839IL/0503) was a multicenter, randomized, parallel-group, open-label, phase II trial that investigated oral gefitinib (250 mg/day) or i.v. docetaxel (75 mg/m2 every 3 weeks) in patients with advanced NSCLC who had previously received one chemotherapy regimen. The primary objective was assessment of symptom improvement (using the FACT-L Lung Cancer Subscale). Secondary objectives included quality of life (FACT-L total score), response rate (using RECIST), overall survival and safety. This trial recruited 141 patients (68 to gefitinib and 73 to docetaxel) who received treatment for a median duration of 3.0 (gefitinib) and 2.8 (docetaxel) months. Similar efficacy was observed with gefitinib and docetaxel, 36.8 and 26.0% symptom improvement rates, 33.8 and 26.0% quality-of-life improvement rates, 13.2 and 13.7% objective response rates, and 7.5 and 7.1 months median overall survival, respectively. Fewer drug-related adverse events were observed with gefitinib compared with docetaxel (all grades: 51.5 versus 78.9%; Common Toxicity Criteria grade 3/4: 8.8 versus 25.4%). There were no withdrawals or deaths due to drug-related adverse events with gefitinib, while three patients withdrew and three died due to adverse events in the docetaxel group that were possibly drug related. We conclude efficacy with gefitinib was similar to docetaxel, but with a more favorable tolerability profile, in the second-line treatment of advanced NSCLC. These results support further investigation of gefitinib in this disease setting.
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PMID:Phase II, open-label, randomized study (SIGN) of single-agent gefitinib (IRESSA) or docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) non-small-cell lung cancer. 1654 97

A Simplified Chinese version of the FACT-L was evaluated using responses from 181 patients with lung cancer in China by assessing the construct, discriminative and criterion-related validity, internal consistency, test-retest reliability, and responsiveness as measured by score changes of the scales. Correlation and factor analysis among domains and items showed good construct validity, correlation analysis of domain scores between FACT-L and Quality of Life Instruments for Cancer Patients-Lung cancer (QLICP-LU) displayed good criterion-related validity, and comparison of two age groups demonstrated discriminative validity. Test-retest reliability and Internal consistency coefficients for all domains were greater than 0.75 with the exception of the domain of additional concerns (alpha=0.56). Score changes over time were statistically significant in the overall scale and all domains: standardized response mean (SRM) for physical well-being is 1.56, social/ family well-being 0.70, emotional well-being 0.93, and functioning well-being 1.51. Therefore, the Simplified Chinese version of FACT-L can be used to measure quality of life (QOL) for Chinese patients with lung cancer with good validity, reliability, and responsiveness.
Lung Cancer 2007 Jun
PMID:Psychometric properties of the Chinese version of the FACT-L for measuring quality of life in patients with lung cancer. 1731 87

Using the structured group methods (nominal and focus group) and the theory in instrument development, the quality of life instrument for lung cancer (QLICP-LU) with Chinese cultural background was developed, and evaluated based on the data from a sample of 85 in-patients of lung cancer. Statistical methods used were correlation analysis, factor analysis and paired t-test, etc. The results showed that test-retest reliability of the overall scale was 0.78, and test-retest reliability and internal consistency alpha for most domains were higher than 0.70; correlation and factor analysis demonstrated good construct validity; criterion-related validity were confirmed given FACT-L and QLQ-LC43 (QLQ-C30 plus QLQ-LC13) as the criterions; statistically significant changes were found for each domain and the overall scale with standardized response mean SRM being greater than 0.80 except for the social function domain. We conclude that the QLICP-LU can be used to measure QOL for patients with lung cancer with better validity, reliability and responsiveness in China.
Lung Cancer 2008 Apr
PMID:Development and validation of the system of quality of life instruments for cancer patients: lung cancer (QLICP-LU). 1796 86


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