Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention website
|
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}
|
| Active Comparator: 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/). |
Behavioral: MUSIC website
Standard of care educational materials {add more detail}
|
Outcome Measures
Primary Outcome Measures
- Feasibility - recruitment [up to 9 months post last patient recruitment]
Defined as the successful recruitment of 40 patients.
- Feasibility - Uptake [up to 6 months post last patient recruitment]
Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.
- Acceptability - Mean Satisfaction Scores [up to 4 months post last patient completing intervention]
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.
Eligibility Criteria
Criteria
Patient Inclusion Criteria:
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55 years old or older
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Men diagnosed with low-risk prostate cancer currently on active surveillance
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Men who identify having a primary care provider
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Access and ability to use the Internet
Patient Exclusion Criteria:
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Men who are unable to read and/or speak English
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan Rogel Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Archana Radhakrishnan, University of Michigan Rogel Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UMCC 2022.059
- HUM00209599
- 5K08CA245237