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

Study Overview
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: web-based tool (MAP- Management of Active surveillance in Prostate Cancer)
* Behavioral: MUSIC website


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention website<br> | Behavioral: web-based tool (MAP- Management of Active surveillance in Prostate Cancer)<br>* 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}<br>|
| Active Comparator: Control MUSIC website<br>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<br>* Standard of care educational materials {add more detail}<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - recruitment | Defined as the successful recruitment of 40 patients. | up to 9 months post last patient recruitment | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-risk, active surveillance