Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening

NCT01484665

Prostate Cancer

COMPLETED NA

Facilitating Shared Decisionmaking About Prostate Cancer Screening

NCT00013247

Prostate Cancer

COMPLETED NA

Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners

NCT02103088

Prostate Cancer

COMPLETED NA

Risk Factors for Chronic Prostatitis Patients in Northwest China

NCT06385977

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

RECRUITING

Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

NCT00335634

Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy Sexual Dysfunction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background: Professional societies recommend shared decision making for prostate cancer screening, however, most effort has been directed at informed rather than shared decision making. In this study, we plan to test the effects of a shared decision making intervention on key components of shared decision making. We secondarily plan to test its effects on the presence of a shared decision, men's intention to be screened, and actual screening rates.

Methods: We plan to conduct two separate randomized controlled trials of shared decision making interventions, one in which the intervention focuses on prostate cancer screening only and one in which the intervention focuses on prostate cancer screening in the context of other men's health issues. Each trial will use the same attention control and identical implementation and measurement strategies to allow combination of data if no differences exist in the effect of the interventions. Trials will include a convenience sample of men with no prior history of prostate cancer who present to their primary care physician for routine care. Men will be randomly assigned to a shared decision making intervention (including a video and coaching session for patients and an education session for providers) or a control group, in which men will receive a video on highway safety. Data on key components of shared decision making and intent for screening will be measured at baseline, after the intervention, and after men's visit with their provider. Additionally, medical charts will be reviewed 9 months later to assess for actual screening.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostatic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with physician

For Physicians: a one-time educational session on prostate cancer and the value of shared decision making

Group Type EXPERIMENTAL

You Decide

Intervention Type OTHER

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician

For Physicians: a one-time educational session on prostate cancer and the value of shared decision making

2

Highway Safety video

Group Type ACTIVE_COMPARATOR

Reducing Your Risks in the Crash

Intervention Type OTHER

Publicly available video on highway safety and reducing individual risks in a crash

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

You Decide

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician

For Physicians: a one-time educational session on prostate cancer and the value of shared decision making

Intervention Type OTHER

Reducing Your Risks in the Crash

Publicly available video on highway safety and reducing individual risks in a crash

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ages 40-80 years
* Their physician agreed to participate in the study
* Seen in practice for at least one year

Exclusion Criteria

* Prior history of prostate cancer
* Presenting for acute medical visit
* Non-skin cancer
* Lung disease requiring oxygen
* Renal failure requiring dialysis
* Intensive care visit in last 6 months
* Need assistance with activities of daily living

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes