Can a computerized format replace a paper form in PRO and HRQL evaluation? Psychometric testing of the computer-assisted LCSS instrument (eLCSS-QL).

PURPOSE: This trial assessed the ability to enhance health-related quality of life (HRQL) and patient-reported outcome (PRO) evaluation in trials and patient management using computer assistance with a handheld device, called a personal digital assistant. The study assessed ease of use and psychometric properties of this approach, comparing the Lung Cancer Symptom Scale (LCSS) paper form with the electronic (eLCSS-QL). Objectives were to: (1) measure completion times; (2) evaluate acceptability by patients, nurses, and physicians; (3) determine the correlation of the eLCSS-QL with the paper version; and (4) determine the feasibility of using a shorter visual analogue scale (VAS) in the electronic version. PATIENTS AND METHODS: Patients were entered at 12 COMET clinics. All had: (a) stage III or IV non-small cell lung cancer, (b) Karnofsky performance status (KPS) ≥ 60, (c) no prior chemotherapy, and (d) received initial courses of docetaxel + platinum. Of the 148 patients enrolled, characteristics were: men, 57 %; median, KPS 80 %; and median age, 67 years. Of these, 131 patients completed the evaluation form. RESULTS: The eLCSS-QL had excellent acceptance by patients, nurses, and physicians. Patients required 2.2 min (mean) to complete the eLCSS-QL. Reliability coefficients using Cronbach's alpha were high for the paper (0.84) and electronic (0.88) versions. The correlation coefficient between forms was high (0.92). The length of the VAS on the handheld pc (53 mm versus 100 mm on the paper format) resulted in nearly identical scores. CONCLUSIONS: The high acceptance rate by patients and professionals, the rapid completion time, ease of use, and strong psychometric properties confirm that the electronic LCSS (eLCSS-QL) is practical for use in trials and patient management. This study indicates that computer assistance helps overcome barriers associated with evaluating HRQL and PROs.

Time to treat: a system redesign focusing on decreasing the time from suspicion of lung cancer to diagnosis.

INTRODUCTION: Multiple investigations often result in a lengthy process from the onset of lung cancer-related symptoms until diagnosis. An unpublished chart audit indicated suboptimal delays in patients' courses from onset of symptoms until diagnosis of cancer. METHODS: The Time to Treat Program was designed for patients with clinical or radiographic suspicion of lung cancer. Pre- and postimplementation data on median wait times were compared. RESULTS: From April 2005 to January 2007, 430 patients were referred. After Time to Treat Program implementation, the median time from suspicion of lung cancer to referral for specialist consultation decreased from 20 days to 6 days, and the median time from such referral to the actual consultation date decreased from 17 days to 4 days. The median time from specialist consultation to computed tomography scan decreased from 52 days to 3 days, and the median time from computed tomography scan to diagnosis decreased from 39 days to 6 days. Overall, the median time from suspicion of lung cancer to diagnosis decreased from 128 days to 20 days. Of all patients in the Time to Treat Program, 33% were eventually diagnosed with lung cancer. CONCLUSIONS: Time to Treat Program was effective in shortening the time from suspicion of lung cancer to diagnosis and reduced time intervals at each step in the process. Earlier diagnosis of lung cancer may allow increased treatment options for patients and may improve outcomes.

Phase II study of vandetanib or placebo in small-cell lung cancer patients after complete or partial response to induction chemotherapy with or without radiation therapy: National Cancer Institute of Canada Clinical Trials Group Study BR.20.

PURPOSE: This double-blind randomized phase II trial examined whether vandetanib, an inhibitor of vascular endothelial and epidermal growth factor receptors, could prolong progression-free survival in responding patients with small-cell lung cancer. PATIENTS AND METHODS: Eligible patients with complete response (CR) or partial response (PR) to combination chemotherapy (+/- thoracic or prophylactic cranial radiation) received oral vandetanib 300 mg/d or matched placebo. With 100 patients and 77 events, the study had 80% power to detect an improvement in median progression-free survival from 4 to 6.5 months (one-sided, 10%-level test). RESULTS: Between May 2003 and March 2006, 107 patients were accrued; 46 had limited disease and 61 extensive disease. There were fewer patients with a performance status of 0 (n = 11 v 20), and fewer had CR to initial therapy (n = 4 v 8) in the vandetanib arm. Vandetanib patients had more toxicity and required more dose modifications for gastrointestinal toxicity and rash. Asymptomatic Corrected QT interval (QTC) prolongation was observed in eight vandetanib patients. Median progression-free survival for vandetanib and placebo was 2.7 and 2.8 months, respectively (hazard ratio [HR], 1.01; 80% CI, 0.75 to 1.36; one-sided P = .51). Overall survival for vandetanib was 10.6 versus 11.9 months for placebo (HR, 1.43; 80% CI, 1.00 to 2.05; one-sided P = 0.9). In planned subgroup analyses, a significant interaction was noted (P = .01): limited-stage vandetanib patients had longer overall survival (HR, 0.45; one-sided P = .07) and extensive-stage vandetanib patients shorter survival compared with placebo (HR, 2.27; one-sided P = .996). CONCLUSION: Vandetanib failed to demonstrate efficacy as maintenance therapy for small-cell lung cancer.