Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study

University of Michigan Rogel Cancer Center40 enrolled

Overview

This is a pilot evaluation of a patient-centered intervention that enables providers to support men on active surveillance to maximize adherence. Conducted in urology practices, this pilot will measure key patient-reported, provider-reported, and implementation outcomes. Successful completion of this work will inform a subsequent multi-center effectiveness-implementation hybrid design trial and ultimately will improve low-risk cancer management by effectively engaging Primary Care Physicians (PCPs) in care delivery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

web-based tool (MAP- Management of Active surveillance in Prostate Cancer)BEHAVIORAL

A web-based tool with modules on active surveillance education, team based active surveillance care delivery and the role of the PCP, and self-management for cancer anxiety and worry. {may need more detail}

MUSIC websiteBEHAVIORAL

Standard of care educational materials {add more detail}

Eligibility

Sex: MALEMin age: 55 Years

Medical Language ↔ Plain English

Patient Inclusion Criteria: * 55 years old or older * Men diagnosed with low-risk prostate cancer currently on active surveillance * Men who identify having a primary care provider * Access and ability to use the Internet Patient Exclusion Criteria: * Men who are unable to read and/or speak English * Men with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) PCP Inclusion Criteria: * Identified by patient on baseline survey as their PCP Urologist and Clinic Staff Inclusion Criteria: * Clinicians or staff at a participating urology clinic, including but not limited to MDs, APPs, and nurses

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Feasibility - recruitment

Defined as the successful recruitment of 40 patients.

Time frame: up to 9 months post last patient recruitment

Feasibility - Uptake

Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.

Time frame: up to 6 months post last patient recruitment

Acceptability - Mean Satisfaction Scores

Acceptability asks the extent to which participants consider the intervention is agreeable. Patients in the intervention arm will answer questions (on a 5-point Likert scale) regarding the use of the tool including: a) the tool provided me the necessary information about being on active surveillance; b) the tool helped me know what tests I needed and when; c) the tool helped me understand what my PCP can do for my active surveillance; d) the tool was easy to use; e) the amount of time it took to go through the website; and f) I would recommend the tool to other patients. We will ask an open-ended question on if the tool should have any other features in future versions. We will additionally collect paradata such as user actions (clicks) and time spent on each webpage.

Time frame: up to 4 months post last patient completing intervention

Data from ClinicalTrials.gov

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