African American Cancer Clinical Trial Decisions: Testing Tailored Messages

Not Applicable

Completed

• Conditions: Lymphoma; Leukemia; Myeloma

• Registration Number: NCT02356549
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-02-01
• Study First Posted: 2015-02-05
• Study Start: 2015-05-01
• Status Verified: 2020-03
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-06
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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).

Exclusions Criteria:

-None

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Demonstrate the efficacy of the tailored health message intervention to increase patient activation.	40 days	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. In this study AA cancer patients will be randomized into one of four experimental groups. Scientifically determine the effectiveness of our intervention by using a composite score for patient activation derived from the Street Patient Activation Coding system.

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States