African American Cancer Clinical Trial Decisions: Testing Tailored Messages

Not Applicable

Completed

• Conditions: Lymphoma; Leukemia; Myeloma
• Interventions: Behavioral: EMR Tailoring; Behavioral: Physician Involvement; Behavioral: Survey Tailoring

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
GROUP 4:EMR+Survey Tailoring+Feedback	EMR Tailoring	Patients will be randomized to receive tailored messages based on information extracted from their EMR as in Group I. Patients will complete a survey that will be used to provide a deeper level of tailored messages as in Group 3. Physicians also receive a summary of tailored messages provided to patients as in Group 2.
GROUP 2:EMR Tailoring+Feedback	EMR Tailoring	Patients will be randomized to receive tailored messages based on information extracted from the EMR as in Group 1. Physicians also receive a summary of tailored messages provided to patients.
GROUP 1: (EMR) Tailoring Alone	EMR Tailoring	Patients will be randomized to receive tailored messages based on demographic and disease information extracted from Massey Cancer Center (MCC) electronic medical records (EMR) that will include a) demographic information: age, income, education and health insurance status, b) disease variables: cancer type and severity and c) trial variables: phase of trial being offered and prior trial participation.
GROUP 3:EMR+Survey Tailoring alone	EMR Tailoring	Patients will be randomized to receive tailored messages based on EMR data as in Group 1. Patients will complete a survey that will be used to provide a deeper level of tailored messages
GROUP 2:EMR Tailoring+Feedback	Physician Involvement	Patients will be randomized to receive tailored messages based on information extracted from the EMR as in Group 1. Physicians also receive a summary of tailored messages provided to patients.
GROUP 3:EMR+Survey Tailoring alone	Survey Tailoring	Patients will be randomized to receive tailored messages based on EMR data as in Group 1. Patients will complete a survey that will be used to provide a deeper level of tailored messages
GROUP 4:EMR+Survey Tailoring+Feedback	Survey Tailoring	Patients will be randomized to receive tailored messages based on information extracted from their EMR as in Group I. Patients will complete a survey that will be used to provide a deeper level of tailored messages as in Group 3. Physicians also receive a summary of tailored messages provided to patients as in Group 2.
GROUP 4:EMR+Survey Tailoring+Feedback	Physician Involvement	Patients will be randomized to receive tailored messages based on information extracted from their EMR as in Group I. Patients will complete a survey that will be used to provide a deeper level of tailored messages as in Group 3. Physicians also receive a summary of tailored messages provided to patients as in Group 2.

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