Prostate Cancer
Conditions
Keywords
low-risk, active surveillance
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.
Interventions
BEHAVIORALweb-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}
BEHAVIORALMUSIC website
Standard of care educational materials {add more detail}
Sponsors
University of Michigan Rogel Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Recruitment | up to 9 months | Defined as the successful recruitment of 40 patients. |
| Feasibility - Uptake | up to 6 months | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORArchana Radhakrishnan
University of Michigan Rogel Cancer Center
Participant flow
Pre-assignment details
4 patients did not complete the baseline survey and were not randomized
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized | 68.2 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
None listed