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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: MUSIC website; Behavioral: web-based tool (MAP- Management of Active surveillance in Prostate Cancer)

• Registration Number: NCT05764005
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-09
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Primary Completion: 2024-03-11
• Study Completion: 2024-03-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control MUSIC website	MUSIC website	This is usual care and all urologists are encouraged to refer their patients to the patient educational materials on the MUSIC website (http://www.musicurology.com/patientmaterials/).
Intervention website	web-based tool (MAP- Management of Active surveillance in Prostate Cancer)	-

Primary Outcome Measures

Name	Time	Method
Acceptability - Mean Satisfaction Scores	up to 4 months post last patient completing intervention	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.
Feasibility - recruitment	up to 9 months post last patient recruitment	Defined as the successful recruitment of 40 patients.
Feasibility - Uptake	up to 6 months post last patient recruitment	Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States