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Completed

NCT Number: NCT05764005

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 website

Behavioral

Standard of care educational materials {add more detail}

Primary outcomes

  1. Feasibility - Recruitment

    Time frame: up to 9 months

    Defined as the successful recruitment of 40 patients.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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