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Addressing Prostate Cancer Information Disparities With eHealth Technology (PCSPrep)

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ClinicalTrials.gov Identifier: NCT02787434
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Jennifer Allen, Tufts University

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).

Condition or disease Intervention/treatment Phase
Prostate Neoplasm Other: Prostate Cancer Screening Decision Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Addressing Prostate Cancer Information Disparities With eHealth Technology
Study Start Date : August 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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.
Other: Prostate Cancer Screening Decision Aid
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.
Other Name: PCSPrep




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787434


Locations
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United States, Massachusetts
Tufts University
Medford, Massachusetts, United States, 02155
United States, Virginia
Emory University Hospital
Atlanta, Virginia, United States
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: Jennifer D Allen, SCD Tufts University
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Responsible Party: Jennifer Allen, Associate Professor, Tufts University
ClinicalTrials.gov Identifier: NCT02787434    
Other Study ID Numbers: 1309011
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data Sharing Plan agreement between Tufts University, Emory University, and Dana-Farber Cancer Institute
Keywords provided by Jennifer Allen, Tufts University:
African american men
prostate cancer screening
web-based decision aid
informed decision making
shared decision-making
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases