Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials.

ABSTRACT:

Background

Symptoms are common among patients enrolled in phase I trials. We assessed the validity of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items in relation to previously validated assessments of quality of life and psychological distress. We used data from a randomized trial testing a palliative care support intervention for patients enrolled on phase I trials.

Methods

Patients (n = 479) were accrued to the parent study prior to initiating a phase I clinical trial with data collected at baseline, 4, and 12 weeks. We determined the correlation of PRO-CTCAE with distress level, Functional Assessment of Cancer Therapy - General (FACT-G) total, and subscale domain scores.

Results

Patients were predominantly f

SUBMITTER: Sedhom R 

PROVIDER: S-EPMC7768928 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature