Trial Outcomes & Findings for Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study (NCT NCT05764005)
NCT ID: NCT05764005
Last Updated: 2026-03-06
Results Overview
Defined as the successful recruitment of 40 patients.
COMPLETED
NA
39 participants
up to 9 months
2026-03-06
Participant Flow
4 patients did not complete the baseline survey and were not randomized
Participant milestones
| Measure |
Intervention Website
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}
|
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/).
MUSIC website: Standard of care educational materials {add more detail}
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Baseline characteristics by cohort
| Measure |
Intervention Website
n=17 Participants
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}
|
Control MUSIC Website
n=18 Participants
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/).
MUSIC website: Standard of care educational materials {add more detail}
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
69.3 years
STANDARD_DEVIATION 6.1 • n=41 Participants
|
68.2 years
STANDARD_DEVIATION 7.9 • n=35 Participants
|
68.7 years
STANDARD_DEVIATION 7.0 • n=76 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
35 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
34 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
33 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=41 Participants
|
18 participants
n=35 Participants
|
35 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: up to 9 monthsDefined as the successful recruitment of 40 patients.
Outcome measures
| Measure |
Total Study Enrollment
n=40 Participants
Total Study Recruitment
|
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/).
MUSIC website: Standard of care educational materials {add more detail}
|
|---|---|---|
|
Feasibility - Recruitment
|
39 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsDefined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.
Outcome measures
| Measure |
Total Study Enrollment
n=35 Participants
Total Study Recruitment
|
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/).
MUSIC website: Standard of care educational materials {add more detail}
|
|---|---|---|
|
Feasibility - Uptake
|
30 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 4 monthsPopulation: Survey was only given to those in the intervention arm
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.
Outcome measures
| Measure |
Total Study Enrollment
n=10 Participants
Total Study Recruitment
|
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/).
MUSIC website: Standard of care educational materials {add more detail}
|
|---|---|---|
|
Acceptability - Mean Satisfaction Scores
MAP Satisfaction 2- Using the MAP program helped me learn about active surveillance.
|
3.30 score on a scale
Standard Deviation 1.34
|
—
|
|
Acceptability - Mean Satisfaction Scores
MAP Satisfaction 3- The MAP program helped me know what tests I needed and when.
|
2.80 score on a scale
Standard Deviation 1.32
|
—
|
|
Acceptability - Mean Satisfaction Scores
MAP Satisfaction 5- The program helped me understand what my PCP can do for my active surveillance.
|
3.40 score on a scale
Standard Deviation 1.35
|
—
|
|
Acceptability - Mean Satisfaction Scores
MAP Satisfaction 8- The MAP program took too much time.
|
4.40 score on a scale
Standard Deviation 0.70
|
—
|
|
Acceptability - Mean Satisfaction Scores
MAP Satisfaction 12- The MAP program was easy to use.
|
3.60 score on a scale
Standard Deviation 1.17
|
—
|
|
Acceptability - Mean Satisfaction Scores
Acceptability- Total
|
3.53 score on a scale
Standard Deviation 0.83
|
—
|
|
Acceptability - Mean Satisfaction Scores
MAP Satisfaction 1 - I would recommend the MAP program to other people
|
3.70 score on a scale
Standard Deviation 0.95
|
—
|
Adverse Events
Intervention Website
Control MUSIC Website
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place