Addressing Prostate Cancer Information Disparities With eHealth Technology

NCT02787434 | Completed DMC

• 1 other identifier: 1309011
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter study that involves research on screening for prostate cancer. This study pilot tests a culturally appropriate decision aid (DA) for African American (AA) men that will empower them to take part in decision-making regarding prostate cancer screening (PCS). The Prostate Cancer Screening Preparation (PCSPrep) tool was designed with intend to be delivered in primary care settings with attention to patient/provider interaction. Funding for this study comes from the National Institute of Health/National Cancer Institute (1R21CA178296).

Conditions

Prostate Neoplasm

Keywords

African american men; prostate cancer screening; web-based decision aid; informed decision making; shared decision-making

Outcome Measures

Primary Outcomes (3)

• Decision self-efficacy

  Confidence in ones ability to gather requisite information and to make an informed decision

  Baseline (T0) upon enrollment into study; immediately following use of decision aid (PCSPrep) approx 30 min after baseline (T1); approximately one hour later, after visiting with primary care provider (T3)

• Prostate cancer screening knowledge

  Knowledge regarding the potential benefits, harms and limitations of prostate cancer screening

  Baseline (T0) upon enrollment into study; immediately following use of decision aid (PCSPrep) approximately 30 minutes after baseline (T1)

• Decisional consistency

  Consistency between decision about screening and stated values regarding the pros and cons of screening

  Baseline (T0) upon enrollment into study; immediately following use of decision aid (PCSPrep) approx 30 min after baseline (T1); approximately one hour later, after visiting with primary care provider (T3)

Study Arms (1)

PCSPrep decision aid

EXPERIMENTAL

All participants recruited to the trial will receive the decision aid. This a one-group study with a quasi-experiemental pre/post evaluation design.

Other: Prostate Cancer Screening Decision Aid

Interventions

Prostate Cancer Screening Decision Aid OTHER

All patients recruited to the study will receive the PCSPrep decision aid. There is only 'study arm.' The Clinical Research Coordinator (CRC) will provide the patient with an iPad to complete the pre-test, PCSPrep and post-test. Individuals will see the survey questions on screen and will hear accompanying audio through headsets. Participants will: (1) be introduced to PCSPrep and the menu of activities/topics; (2) enter information about themselves for personal tailoring (e.g., risk factors); (3) participate in a values-clarification exercise to rate the personal importance of varied courses of action (i.e., pros/cons of PCS); (4) receive a printout with an individualized plan for discussing PCS with their primary care provider.

Also known as: PCSPrep

PCSPrep decision aid

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African american men,
• ages 45-70 who are able to provide informed consent to participate in the educational intervention and associated data collection activities.
• English speaking

You may not qualify if:

• no prior personal history of prostate cancer
• no prior prostate cancer screening with the prostate specific antigen test within preceding three years
• inability to speak English

Sponsors & Collaborators

• Tufts University: lead

Study Sites (2)

Tufts University

Medford, Massachusetts, 02155, United States

Location

Emory University Hospital

Atlanta, Virginia, United States

Location

Related Publications (1)

• Allen JD, Porteny T, Kaplan A, Ladin K, Monahan K, Berry DL. Does Shared Decision-Making for Prostate Cancer Screening Among African American Men Happen? It Depends on Who You Ask. J Racial Ethn Health Disparities. 2022 Aug;9(4):1225-1233. doi: 10.1007/s40615-021-01064-x. Epub 2021 Jun 15.

  PMID: 34129229 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jennifer D Allen, SCD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: June 1, 2016
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)