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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00209599 | Other Identifier | University of Michigan | |
| 5K08CA245237 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention website | Experimental |
| |
| Control MUSIC website | Active Comparator | 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/). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| web-based tool (MAP- Management of Active surveillance in Prostate Cancer) | Behavioral | 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} |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Recruitment | Defined as the successful recruitment of 40 patients. | up to 9 months |
| 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 |
| 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. 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 |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
PCP Inclusion Criteria:
Urologist and Clinic Staff Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Archana Radhakrishnan | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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4 patients did not complete the baseline survey and were not randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | 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} |
| FG001 | 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} |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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} |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility - Recruitment | Defined as the successful recruitment of 40 patients. | Posted | Count of Participants | Participants | up to 9 months |
|
|
Patients were monitored while on study for an average of 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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} |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2023 | Jul 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| MUSIC website | Behavioral | Standard of care educational materials {add 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} |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| 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. 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. | Survey was only given to those in the intervention arm | Posted | Mean | Standard Deviation | score on a scale | up to 4 months |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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} | 0 | 18 | 0 | 18 | 0 | 18 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
| MAP Satisfaction 3- The MAP program helped me know what tests I needed and when. |
|
| MAP Satisfaction 5- The program helped me understand what my PCP can do for my active surveillance. |
|
| MAP Satisfaction 8- The MAP program took too much time. |
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| MAP Satisfaction 12- The MAP program was easy to use. |
|