Study design and participants
tumor, death, Anxiety, postbiopsy, Prostate, Depression, Cancer
CANCER, TUMOR, METASTASIS, PROSTATE, PROSTATE CANCER, BROWN
From 2016 to 19 we enrolled 200 men into a randomized controlled trial, ENACT (Engaging Newly Diagnosed Men About Cancer Treatment Options) from three sites: the University of Illinois at Chicago (UIC), John H. Stroger Jr Hospital of Cook County (Cook County), and the Jesse Brown VA Medical Center.At their first postbiopsy visit (Visit 1), participants were randomly assigned to Intervention (GPS testing) or Control (no GPS testing), using a block random assignment scheme stratified on trial site and NCCN risk level. Participants would discuss their PCa diagnosis and received brief standardized counseling at this visit to describe the NCCN risk group and guideline‐based treatment options. Baseline demographic and clinical data were collected, including urinary (International Prostate Symptom Score) and sexual function (International Index of Erectile Function), health literacy (Chew's Brief Health Literacy Survey), and psychometric (e.g., Memorial Anxiety Scale for prostate cancer, Hospital Anxiety and Depression scale) indicators. For participants in the Intervention arm, study pathologists selected tumor blocks containing the highest grade and then prioritized the core with the largest tumor volume; tissue sections or blocks were sent to Genomic Health, Inc. for analysis. After 2–3 weeks, participants returned for their second postbiopsy visit (Visit 2), at which time they would go over their GPS report (if they were in the Intervention group), and receive standardized NCCN guideline‐based counseling to decide on a treatment strategy. The GPS report format underwent some changes during the duration of the trial. Version 1 and 2 only differed in the graphical display but presented the same information; versions 3 of the report added estimates of the 10‐year likelihood of metastasis and PCa death. The majority of patients received version 3 (70 participants), 20 received version 2, and only one received the first version.