Kaiser Permanente
Los Angeles, California, 90027, United States
NCT Number: NCT07207902
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.
This study is active but is not currently recruiting participants.
Notify Me40 year–80 year
Male
Interventional
Not applicable
Los Angeles, California, 90027, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 minute explainer video on treatment options
Time frame: 12 months
Incidence of surveillance, focal therapy, or other treatment choice
Time frame: 12 months
Anxiety and Decision Regret Score
Kaiser Permanente
Other
Surveillance or Focal Therapy (SOFT) for Prostate Cancer
Acronym: SOFT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06441994
Genital Diseases, Genital Diseases, Male
Suita, Osaka, Japan
View Trial DetailsNCT00352924
Blood Protein Disorders, Cardiovascular Diseases
Research Triangle Park, North Carolina, United States
View Trial DetailsNCT03957252
Disease, Genital Diseases
Baltimore, Maryland, United States
View Trial DetailsNCT04589468
Behavior, Breast Cancer
Duarte, California, United States
View Trial Details