Back to resultsOptimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
web-based tool (MAP- Management of Active surveillance in Prostate Cancer)
MUSIC website
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Cancer focused on measuring low-risk, active surveillance
Eligibility Criteria
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
Sites / Locations
- University of Michigan Rogel Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention website
Control MUSIC website
Arm Description
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/).
Outcomes
Primary Outcome Measures
Feasibility - recruitment
Defined as the successful recruitment of 40 patients.
Feasibility - Uptake
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05764005
First Posted
February 28, 2023
Last Updated
August 8, 2023
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05764005
Brief Title
Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Official Title
Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
low-risk, active surveillance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention website
Arm Type
Experimental
Arm Title
Control MUSIC website
Arm Type
Active Comparator
Arm Description
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/).
Intervention Type
Behavioral
Intervention Name(s)
web-based tool (MAP- Management of Active surveillance in Prostate Cancer)
Intervention Description
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}
Intervention Type
Behavioral
Intervention Name(s)
MUSIC website
Intervention Description
Standard of care educational materials {add more detail}
Primary Outcome Measure Information:
Title
Feasibility - recruitment
Description
Defined as the successful recruitment of 40 patients.
Time Frame
up to 9 months post last patient recruitment
Title
Feasibility - Uptake
Description
Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.
Time Frame
up to 6 months post last patient recruitment
Title
Acceptability - Mean Satisfaction Scores
Description
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.
Time Frame
up to 4 months post last patient completing intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer AnswerLine
Phone
1-800-865-1125
Email
CancerAnswerLine@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Archana Radhakrishnan
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer AnswerLine
Phone
800-865-1125
Email
CancerAnswerLine@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Archana Radhakrishnan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
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