Trial Title:
Evaluation of an Online Prostate Cancer Screening Decision Aid
NCT ID:
NCT06610474
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Decision Aid
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Use of the online "Talk to Nathan about Prostate Cancer" decision aid
Description:
This decision aid is publicly available at this website in both English or Spanish:
https://www.cdc.gov/prostate-cancer/talk-to-nathan/index.html
Arm group label:
Talk to Nathan
Intervention type:
Behavioral
Intervention name:
Use of a standard prostate cancer screening decision aid
Description:
The standard decision aid is available here and will be used in either English or
Spanish: https://massclearinghouse.ehs.state.ma.us/PROG-CANC/CA1382kit.html
Arm group label:
Standard decision aid
Intervention type:
Behavioral
Intervention name:
Use of standard prostate cancer education materials
Description:
The standard education materials are available from the National Cancer Institute (NCI)
website in English or Spanish:
https://www.cancer.gov/types/prostate/patient/prostate-screening-pdq
Arm group label:
Standard education materials
Summary:
The goal of this clinical trial is to learn if the online, simulated human "Talk to
Nathan About Prostate Cancer Screening" decision aid
(https://www.cdc.gov/prostate-cancer/talk-to-nathan/index.html) is effective in helping
patients decide about prostate cancer screening. The main questions it aims to answer
are:
- Is using the "Talk to Nathan About Prostate Cancer Screening" decision aid effective
in improving knowledge, overcoming health literacy barriers, and resolving
decisional conflict compared to a standard decision aid or standard education
materials?
- What are the barriers and best practices for incorporating Talk to Nathan About
Prostate Cancer Screening into the flow of primary care practice?
Researchers will compare "Talk to Nathan About Prostate Cancer Screening" to a standard
decision aid and to standard prostate cancer screening education materials to test the
effectiveness of using "Talk to Nathan About Prostate Cancer Screening."
Participants will:
- Use "Talk to Nathan About Prostate Cancer Screening," use a standard decision aid,
or use standard education materials about prostate cancer screening
- Visit the primary care clinic for follow-up
- Complete surveys as part of the clinical trial
Detailed description:
Goal of the project: To conduct a randomized controlled trial (RCT) to determine if CDC's
online, simulated, human decision aid module, Talk to Nathan About Prostate Cancer
Screening (treatment arm), is effective in improving knowledge, overcoming health
literacy barriers, and resolving decisional conflict compared to a standard decision aid
(control arm 1) and standard education materials (control arm 2). Also, to identify
barriers and best practices for incorporating Talk to Nathan About Prostate Cancer
Screening into the flow of primary care practice.
Intended use of the resulting data: To measure evaluation outcomes, understand how to
help men make decisions about the harms and benefits of prostate cancer screening that
are in line with the patient's individual values and preferences, and make
recommendations for improving the Talk to Nathan About Prostate Cancer Screening decision
aid and incorporating it into primary care practice.
Methods to be used to collect: The RCT is a three-group parallel design with one
treatment arm and two control arms. Data will be collected from all arms using a
pre-exposure survey, a post-exposure survey, and a post-clinic visit survey. The
treatment arm will also complete a usability survey and a subset of the treatment arm
will be invited to participate in user experience interviews. Health care providers at
the four participating clinics will complete a short survey prior to executing the
three-arm study and interviews will be conducted at the close of the study with study
coordinators from the four participating clinics.
The subpopulation to be studied: For the pre- and post-surveys, the usability survey, and
the user experience interviews, the subpopulation is men aged 55-69 years. For the
provider survey, the subpopulation is primary care providers who practice within the four
clinics participating in the study. For the clinic coordinator interviews, the
subpopulation is the study coordinators from the four participating clinics.
How data will be analyzed: For quantitative survey data: intention-to-treat analysis;
repeated measures analysis of variance across assessment time points; ordinary least
squares regression; complier-average causal effect (CACE) approach to calculate treatment
effect; maximum likelihood and Bayesian inferential methods for CACE. For qualitative
data from the surveys and interviews: We will identify and analyze themes, patterns, and
inter-relationships relevant to the evaluation questions for this study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Assigned male at birth.
- Aged 55-69 years.
- Scheduled for an upcoming health exam.
- Has access to the internet.
- Has a valid email address or valid mobile phone number with SMS capabilities.
- Speaks and reads English or Spanish.
Exclusion Criteria:
- Refuses to participate.
- Currently has urinary tract symptoms (i.e., difficulty starting urination; weak or
interrupted flow of urine; urinating often, especially at night; trouble emptying
the bladder completely; pain or burning during urination; blood in the urine or
semen; pain in the back, hips, or pelvis that doesn't go away; or painful
ejaculation).
- Prior history of prostate cancer.
- Scheduled for, undergoing, or has had a prostate biopsy.
- A previous PSA score is contained in the patient's health record and it is > 3 ng/mL
and/or a very suspicious digital rectal exam (DRE) result (defined as the presence
of significant induration, nodularity, or asymmetry).
- Patient has a terminal illness, significant psychiatric comorbidity (identified by
clinic coordinator), cognitive deficits, or reports of ongoing substance misuse.
Gender:
Male
Minimum age:
55 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
East Northport Medical Care
Address:
City:
E. Northport
Zip:
11731
Country:
United States
Contact:
Last name:
Nancy Sacco, PhD
Phone:
847-345-3931
Email:
nancy.sacco@sitebridgeresearch.com
Contact backup:
Last name:
Bharat Patel, MBA
Phone:
(586) 876-4151
Email:
bharat.patel@sitebridgeresearch.com
Facility:
Name:
Alliance Medical Ministry
Address:
City:
Raleigh
Zip:
27610
Country:
United States
Contact:
Last name:
Nancy Sacco, PhD
Phone:
847-345-3931
Email:
nancy.sacco@sitebridgeresearch.com
Contact backup:
Last name:
Bharat Patel, MBA
Phone:
(586) 876-4151
Email:
bharat.patel@sitebridgeresearch.com
Start date:
October 2024
Completion date:
September 2025
Lead sponsor:
Agency:
David Siegel
Agency class:
U.S. Fed
Collaborator:
Agency:
ICF Macro, Inc.
Agency class:
Other
Source:
Centers for Disease Control and Prevention
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06610474
