Richmond, Virginia 23298


Purpose:

The purpose of this study is to determine if the use of tailored health messages and/or involving physicians are effective in increasing African American (AA) patient activation in a clinical trial consultation. The proposal will use a composite score for patient activation derived from the Street Patient Activation Coding system. This will help to determine the effectiveness of our intervention on patient activation and patient centered clinical trial decision.


Study summary:

A randomized clinical trial (using a 2x2 factorial design) to inform our knowledge of the efficacy of a tailored health message intervention, using different depths of tailoring and involving physicians, on AA cancer patients' active communication in CT consultations as measured by the Street Patient Activation measure. In this study 357 AA cancer patients will be randomized into one of four experimental groups Group 1 - messages tailored on Electronic Medical Record (EMR) data. Group 2 - messages tailored on EMR + physician involvement. Group 3 - messages tailored on EMR + survey. Group 4 - Messages tailored on EMR + survey + physician involvement. We will also measure patient: a) trust in their physician, b) trust in medical research, c) preferences that include information and decision involvement, d) communication self-efficacy, e) patient-family member communication congruence, f) consultation satisfaction and g) decision outcomes that include decisional conflict, decision satisfaction and decision regret.


Criteria:

Inclusion: - 21 years of age or older - Have a cancer diagnosis - Self identify as African American - Therapeutic Phase I, II or III clinical trial at Massey Cancer Center (regardless of whether or not they join the therapeutic trial) - Be able to provide informed consent - We will also recruit one family member/caregiver (N = 357) of each participating patient - Consented patients will not be excluded from this study if their family member declines to participate by completing the Cancer Communication Assessment Tool for Families (CCAT-F).


NCT ID:

NCT02356549


Primary Contact:

Principal Investigator
Richard Brown, Ph.D.
Virginia Commonwealth University

Richard Brown, Ph.D.
Phone: 804-628-3340
Email: rbrown39@vcu.edu


Backup Contact:

Email: wardjf@vcu.edu
Jamesha Ward
Phone: 804-628-3826


Location Contact:

Richmond, Virginia 23298
United States

Richard Brown, PhD
Phone: 804-628-3340
Email: rbrown39@vcu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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