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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05764005
Other study ID # UMCC 2022.059
Secondary ID HUM002095995K08C
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 9, 2022
Est. completion date May 2024

Study information

Verified date November 2023
Source University of Michigan Rogel Cancer Center
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 40
Est. completion date May 2024
Est. primary completion date May 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

Study Design


Related Conditions & MeSH terms


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
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