Lead Investigator: Andrew Bottomley, European Organisation for Research and Treatment of Cancer (EORTC)
Title of Proposal Research: Cancer Clinical Trials Pooling of Quality Life Data (CATAPULT) initiative
Vivli Data Request: 7162
Funding Source: This project has received independent funding from EORTC Quality of Life Group (RP1619) and is purely an academic undertaking. The budget will be used to fund three years (2018-2021) project and will cover all the costs related.
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Patient-centered care is a critical component in quality health care; and patient-reported health-related quality of life (HRQoL) is one of the best ways to capture patient-centeredness. The utility of patient perspective and HRQoL can enable the investigation of significant but neglected topics relating to HRQoL in various areas of clinical cancer trials research. To respond to this need, the European Organisation for Research and Treatment of Cancer (EORTC) set-up and spearheaded the Patient-Reported Outcomes and Behavioral Evidence (PROBE). PROBE combined HRQoL data from over 17,000 individual patients from different cancer clinical trials and disease stages, offering a robust resource to address research questions relating to HRQoL. Although the insights gained from PROBE have been pivotal in moving the research on HRQoL forward, we have identified three critical issues that need to be addressed:
• PROBE focused mainly on EORTC and Canadian Cancer Trials Group (CCTG) closed clinical trials, it is imperative that key PROBE findings are validated in a separate dataset to increase the generalizability of the findings.
• Although PROBE provided a large database of HRQoL data in cancer randomised clinical trials (RCTs) from several disease sites, this dataset is also constrained because data from specific disease sites were limited.
• Several important HRQoL research questions were not addressed in PROBE, such as (a) validating more advanced psychometric analyses of HRQoL data, (b) exploring alternative ways of understanding HRQoL scores, and (c) examining longitudinal HRQoL data to answer critical questions.
Therefore, to address the above issues, the EORTC is leading a new initiative: Cancer Clinical Trials Pooling of Quality Life Data (CATAPULT) that seeks to assemble a more complete database of HRQoL from closed cancer RCTs and validate selected key findings from PROBE across disease sites and across clinical trials conducted by different groups.
Requested Studies:
BMS study
Data Contributor: Bristol Myers Squibb
Study ID: CA184-169
Sponsor ID: CA184-169
BMS study
Data Contributor: Bristol Myers Squibb
Study ID: CA184-104
Sponsor ID: CA184-104
BMS study
Data Contributor: Bristol Myers Squibb
Study ID: CA184-156
Sponsor ID: CA184-156
Update: This data request was withdrawn on 8-Apr-2022 by the researcher.