Feasibility of quality of life assessment in a randomized phase III trial of small cell lung cancer

Abstract

Between 1985 and 1990 the Swiss Group for Clinical Cancer Research (SAKK) for the first time assessed quality of life (QL) variables in 188 patients in a multicenter small-cell lung cancer trial that compared two different regimens of combination chemotherapy. QL-assessment was scheduled at the beginning of each of the six treatment cycles. The self-rating QL questionnaire included an early version of the EORTC QL questionnaire, a mood adjective checklist (Bf-S) and a single linear analogue scale (LASA) measuring general well-being. Compliance with completion of the scheduled questionnaires varied between 37% and 58% over the six cycles, and between 21% and 68% among the 7 participating institutions. Mean compliance was 49%. The institution was found the only significant factor predicting compliance (p < 0.001). Patient age, sex, education and biological prognostic factors at randomization were not predictors of compliance. Although compliance was poor, the data received was of high quality. We suggest practical guidelines for improving compliance with QL data collection in multicenter clinical trials.

Randomized Trial Comparing the two Different Hypofractionated Radiotherapy Schedules (20Gy in 5 Fractions versus 17Gy in 2 Fractions) in Advanced Non-small Cell lung Cancer (Stage IV)

“…No cases of any grade of radiation induced myelopathy or pneumonitis were detected in any of the patients in both arms during the follow up times. These results are in accordance with some previous randomized trials which reported dysphagia as main toxicity of treatment with no differences among different fractionation schedules used in these trials 9,12 while other trials reported more dysphagia in the short course hypofractionated arm 15 and two trial reported more dysphagia in the more protracted regimen 16 .…”

“…The major concern related to the use of hypo fractionated treatment schedules is their potential inferiority in terms of overall survival as shown in three RCTs 15 . Some evidence exists that higher RT doses result in a modest increase in survival, although at the expense of higher acute toxicity 16 .…”

Timing of quality of life (QoL) assessments as a source of error in oncological trials

“…(1998) allowed a window of ±2 weeks; measurements within 2 weeks following randomization were regarded as the baseline measurement and measurements during weeks 3–6 were regarded as follow‐up measurements. Hürny et al . (1992) accepted 0–8 days before the beginning of the cycle as correctly scheduled questionnaires.…”

The Analysis, Interpretation, and Presentation of Quality of Life Data

“…Compliance, the number of forms completed at the correct timepoint as a proportion of the number expected, has been reported to range from 23% to 96% in various trials (Hurny et al, 1992). Compliance, the number of forms completed at the correct timepoint as a proportion of the number expected, has been reported to range from 23% to 96% in various trials (Hurny et al, 1992).…”