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

NCT05764005 | Completed Results DMC

• 3 other identifiers: UMCC 2022.059HUM002095995K08CA245237
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

low-risk; active surveillance

Outcome Measures

Primary Outcomes (3)

• Feasibility - Recruitment

  Defined as the successful recruitment of 40 patients.

  up to 9 months

• Feasibility - Uptake

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

  up to 6 months

• 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. 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.

  up to 4 months

Study Arms (2)

Intervention website

EXPERIMENTAL

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

Control MUSIC website

ACTIVE COMPARATOR

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/).

Behavioral: MUSIC website

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}

Intervention website

MUSIC website BEHAVIORAL

Standard of care educational materials {add more detail}

Control MUSIC website

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Identified by patient on baseline survey as their PCP
• Clinicians or staff at a participating urology clinic, including but not limited to MDs, APPs, and nurses

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• Archana Radhakrishnan

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: November 9, 2022
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Locations

US (1)