Addressing Prostate Cancer Information Disparities With eHealth Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Prostate cancer screening knowledge
Study Overview
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).
Detailed Description
STUDY AIMS AIM 1: Among AA men ages 45-70, estimate the impact of PCSPrep on primary outcomes: (a) knowledge; (b) confidence in ability to make informed decisions and communicate with provider; (c) consistency between values & PCS preferences.
AIM 2: Among primary care providers, to assess secondary outcomes: (a) perceptions regarding patient engagement in SDM; and (b) concordance with patient's ratings of SDM.
AIM 3: Among patients, providers and clinic staff, document the feasibility and acceptability of integrating PCSPrep into primary care practices.
RECRUITMENT & ENROLLMENT
Primary Care Providers Recruitment:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
PCSPrep decision aid
All participants recruited to the trial will receive the decision aid. This a one-group study with a quasi-experiemental pre/post evaluation design.
Intervention: Prostate Cancer Screening Decision Aid (Other)
Outcomes
Primary Outcomes
Prostate cancer screening knowledge
Time Frame: Baseline (T0) upon enrollment into study; immediately following use of decision aid (PCSPrep) approximately 30 minutes after baseline (T1)
Knowledge regarding the potential benefits, harms and limitations of prostate cancer screening
Decision self-efficacy
Time Frame: 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)
Confidence in ones ability to gather requisite information and to make an informed decision
Decisional consistency
Time Frame: 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)
Consistency between decision about screening and stated values regarding the pros and cons of screening
Secondary Outcomes
No secondary outcomes reported
Investigators
Jennifer Allen
Associate Professor
Tufts University