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

NCT ID: NCT05764005

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2024-03-11

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention website

Group Type EXPERIMENTAL

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

Intervention Type 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}

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/).

Group Type ACTIVE_COMPARATOR

MUSIC website

Intervention Type BEHAVIORAL

Standard of care educational materials {add more detail}

Interventions

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

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 Type BEHAVIORAL

MUSIC website

Standard of care educational materials {add more detail}

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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

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)
Minimum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Archana Radhakrishnan

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00209599

Identifier Type: OTHER

Identifier Source: secondary_id

5K08CA245237

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2022.059

Identifier Type: -

Identifier Source: org_study_id

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