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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764005
• Other study ID #: UMCC 2022.059
• Secondary ID: HUM002095995K08C
• Status: Completed
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: March 11, 2024

Study information

• Verified date: June 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• 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}
• MUSIC website
Standard of care educational materials {add more detail}

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - recruitment	Defined as the successful recruitment of 40 patients.	up to 9 months post last patient recruitment
Primary	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 post last patient recruitment
Primary	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.	up to 4 months post last patient completing intervention