Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention website
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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}
|
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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/).
|
Standard of care educational materials {add more detail}
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Recruitment
Time Frame: up to 9 months
|
Defined as the successful recruitment of 40 patients.
|
up to 9 months
|
|
Feasibility - Uptake
Time Frame: up to 6 months
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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
|
|
Acceptability - Mean Satisfaction Scores
Time Frame: up to 4 months
|
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. Mean score will be provided from a scale of 1-5 for each question. 5 indicating greater acceptability. The name of the web-based tool being studied is MAP- Management of Active surveillance in Prostate Cancer. |
up to 4 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Archana Radhakrishnan, University of Michigan Rogel Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCC 2022.059
- HUM00209599 (Other Identifier: University of Michigan)
- 5K08CA245237 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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