This trial studies how well decision-making aid works in helping participants with low-risk prostate cancer make informed treatment decisions. Decision-making aids that help with the prostate decision-making process may help participants be more informed about treatment and management decisions.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03397160.
PRIMARY OBJECTIVES:
I. Increase the rate of informed decision-making among men with early-stage prostate cancer.
SECONDARY OBJECTIVES:
I. Assess the effect of decision support on anxiety, decision self-efficacy, and decision quality, as measured by validated survey instruments, and management choice.
OUTLINE: At the onset, a participating site is randomized to either usual care or intervention phase/arm. After accrual of 20 participants, the site crosses over to the other arm (intervention or usual care) to accrue the remaining 20 participants. The randomization ordering schema was pre-ordained by the study biostatistician, Dr. John Neuhaus.
GROUP I: Participants receive usual care.
GROUP II: Participants receive access to print or web-based decision aid. Participants then attend meeting with trained coach to discuss decision aid to prepare for doctors visit.
After completion of study, participants are followed up annually.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorPeter R. Carroll