NCT02356549

African American Cancer Clinical Trial Decisions: Testing Tailored Messages

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myeloma
• Lymphoma
• Leukemia

Interventions

Type	Name	Description
BEHAVIORAL	EMR Tailoring	Electronic Medical Records (EMR) data alone will be entered into the Michigan Tailoring System (MTS system) and their brochures will be prepared.
BEHAVIORAL	Survey Tailoring	Survey that will use standardized, psycho-metrically sound measures to gather information about patients, including their levels of trust in medical research and preferences for information and decision involvement. The survey augmented by their EMR data will be used to develop a level of tailored messages.
BEHAVIORAL	Physician Involvement	Prior to the consultation, physicians of patients will receive a summary of patients' tailored message brochure from the Research Assistant (RA) and included in the patient's notes. At the conclusion of the consultation, the RA will ask the oncologist whether or not a clinical trial was discussed and whether or not they read the patients brochure.

Timeline

• Start date: 2015-05-01
• Primary completion: 2020-03-06
• Completion: 2020-03-06
• First posted: 2015-02-05
• Last updated: 2020-04-01

Locations

1 site across 1 country: United States