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Clinical Trials/NCT05764005
NCT05764005
Completed
N/A

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

University of Michigan Rogel Cancer Center1 site in 1 country39 target enrollmentNovember 9, 2022

Overview

Phase
N/A
Intervention
web-based tool (MAP- Management of Active surveillance in Prostate Cancer)
Conditions
Prostate Cancer
Sponsor
University of Michigan Rogel Cancer Center
Enrollment
39
Locations
1
Primary Endpoint
Feasibility - Recruitment
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 9, 2022
End Date
March 11, 2024
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

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

Arms & Interventions

Intervention website

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

Control 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: MUSIC website

Outcomes

Primary Outcomes

Feasibility - Recruitment

Time Frame: up to 9 months

Defined as the successful recruitment of 40 patients.

Feasibility - Uptake

Time Frame: up to 6 months

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

Acceptability - Mean Satisfaction Scores

Time Frame: up to 4 months

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. Mean score will be provided from a scale of 1-5 for each question. 5 indicating greater acceptability. The name of the web-based tool being studied is MAP- Management of Active surveillance in Prostate Cancer.

Study Sites (1)

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