Prostate Cancer
Conditions
Keywords
prostate cancer, focal therapy, active surveillance
Brief summary
Patients with newly diagnosed low-intermediate risk prostate cancer often are not advised of all the options in an easy to understand way. This trial will show patients a 2 minute animated Explainer video to better understand their treatment options. Patients will choose their treatment choice (surveillance, focal therapy, or standard treatment option) and we will determine disease related anxiety and decision regret scores.
Detailed description
Low risk prostate cancer is usually monitored with active surveillance (AS). Some evidence suggests no differences in health-related quality of life (HRQoL) and wellness between men undergoing AS and those receiving treatment. However, other studies have shown a significant subset of patients suffers from anxiety or depression related to disease uncertainty. Many patients are given an all-or-none binary choice between monitoring or radical treatment. Focal therapy (FT), however, is a potentially less intense treatment option that exists between these extreme choices but is not always presented to the patient due to provider variability. This study seeks to define the proportion of newly diagnosed low/low-int risk prostate cancer patients who elect to pursue HIFU or surveillance when presented with all treatment options devoid of persuasive rhetoric using an animated explainer video. Secondary outcomes will include anxiety score and decision regret.
Interventions
BEHAVIORALExplainer video
2 minute explainer video on treatment options
Sponsors
Kaiser Permanente
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Gleason 3+3 (GG 1) or 3+4 (GG2) * ≤4 cores * T1c-T2 * Prostate \< 60cc * MRI non-focal or PIRADS 3-4 in peripheral gland * Absence of significant anterior disease
Exclusion criteria
* Anal stenosis * Prostatic calfcifations * Latex allergy * Gleason grade group 3-5 * Multifocal or anterior disease * Prostate \> 60 cc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment choice | 12 months | Incidence of surveillance, focal therapy, or other treatment choice |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decision regret and anxiety scale | 12 months | Anxiety and Decision Regret Score |
Countries
United States
Outcome results
None listed