Health-related Quality Of Life In Phase Research Articles

How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials

Traditionally, the efficacy of cancer treatment in patients with advance or metastatic disease in clinical studies has been studied using overall survival and more recently tumor-based end points such as progression-free survival, measurements of response to treatment. However, these seem not to be the relevant clinical end points in current situation if such end points were no validated as surrogate of overall survival to demonstrate the clinical efficacy. Appropriate, meaningful, primary patient-oriented and patient-reported end points that adequately measure the effects of new therapeutic interventions are then crucial for the advancement of clinical research in metastatic colorectal cancer to complement the results of tumor-based end points. Health-related quality of life (HRQoL) is effectively an evaluation of quality of life and its relationship with health over time. HRQoL includes the patient report at least of the way a disease or its treatment affects its physical, emotional and social well-being. Over the past few years, several phase III trials in a variety of solid cancers have assessed the incremental value of HRQoL in addition to the traditional end points of tumor response and survival results. HRQoL could provide not only complementary clinical data to the primary outcomes, but also more precise predictive and prognostic value. This end point is useful for both clinicians and patients in order to achieve the dogma of precision medicine. The present article examines the use of HRQoL in phase III metastatic colorectal cancer clinical trials, outlines the importance of HRQoL assessment methods, analysis, and results presentation. Moreover, it discusses the relevance of including HRQoL as a primary/co-primary end point to support the progression-free survival results and to assess efficacy of treatment in the advanced disease setting.

An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma

ObjectivesThe objective of this study was to explore the association between health-related quality of life (HRQoL) and the recommended phase 2 dose in a phase I clinical trial according to...

The Pediatric Cancer Quality of Life Inventory-32 (PCQL-32). II. Feasibility and range of measurement.

The Pediatric Cancer Quality of Life Inventory-32 (PCQL-32) has been developed to be a standardized assessment instrument to assess systematically pediatric cancer patient's health-related quality of life (HRQOL) outcomes. Multidimensional serial measurement of pediatric cancer patients' HRQOL in Phase III randomized controlled clinical trials is increasingly being recognized as an essential component in evaluating the comprehensive health outcomes of modern antineoplastic treatment protocols. The 32-item PCQL-32 short form was empirically derived from the PCQL long form (84-87 items), which was administered to 291 pediatric cancer patients and their parents during various stages of treatment. The feasibility (percentage of missing values per item) and range of measurement [percentage of minimum (floor effect) and maximum (ceiling effect) possible scores] was calculated for the five PCQL-32 scales and the total scale score. Feasibility for the PCQL-32 was very good, with less than .01% missing values. Range of measurement was full, with no ceiling effects (higher symptoms/problems) and low to moderate floor effects (lower symptoms/problems). The PCQL-32 demonstrated very good feasibility and range of measurement. In its short form, the PCQL-32 is practical for Phase III clinical trials. Future studies will test the utility of the PCQL-32 as a brief serial measure for monitoring the HRQOL outcomes for children and adolescents with cancer.