Project Details
Description
PROJECT ABSTRACT
In cancer clinical trials, it is essential to understand and communicate the negative impact of drugs on patient
participants in order to balance risks and benefits. Symptom side effects such as nausea and diarrhea are
particularly common and impactful on the patient experience. However, historically this information has been
reported by clinicians on behalf of their patients rather than by patients themselves – a process that has been
shown to miss up to half of patients' symptoms. Therefore, the National Cancer Institute (NCI) supported
development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse
Events (PRO-CTCAE), a library of questions to enable systematic patient self-reporting of side effect
information. To date, the PRO-CTCAE questions have been developed and tested for validity and feasibility of
use in clinical trials – work that was led by the investigators on this proposal under contracts to the NCI.
However, it is not yet established how best to combine PRO-CTCAE information with traditional measures of
treatment impact such as clinician-reported adverse events, time on treatment, drug dose levels, performance
status, and hospitalizations. The purpose of this supplement is to complete work towards understanding the
role of the PRO-CTCAE in combination with these traditional measures of treatment impact in assessments of
drug tolerability. In this supplement, advanced statistical methods will be used to analyze data from
newly available clinical trials, delayed by the pandemic, accessible to the team through the National
Clinical Trial Network (cooperative groups) and industry. The specific aims are to: 1) characterize
relationships between the PRO-CTCAE and traditional measures of treatment impact and tolerability; 2)
test and standardize analytic techniques for the PRO-CTCAE; 3) refine approaches to analyzing missing
PRO-CTCAE data; and 4) develop and refine tabular and graphical data visualizations for longitudinal
PRO-CTCAE data. To accomplish these aims, our multi-disciplinary team will work collaboratively and
flexibly with other investigators and stakeholders through the U01 consortium chaired by Dr. Amylou Dueck,
and will continue to share data, statistical programming code, and ideas freely. This work is intended to
inform best practices for tabulating and reporting PRO-CTCAE data, and will enable more systematic
and patient-centered evaluations of tolerability in cancer clinical trials. This supplement will extend the grant
by 12 months.
Status | Finished |
---|---|
Effective start/end date | 9/30/18 → 8/31/23 |
Funding
- National Cancer Institute: $469,493.00
- National Cancer Institute: $530,934.00
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