African American Cancer Clinical Trial Decisions: Testing Tailored Messages

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Lymphoma; Myeloma; Leukemia

Treatments: Behavioral: EMR Tailoring; Behavioral: Physician Involvement; Behavioral: Survey Tailoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02356549

MCC-14-10762

NCI-2015-01819 (Registry Identifier)

HM20002965 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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90 participants in 4 patient groups

GROUP 1: (EMR) Tailoring Alone

Active Comparator group

Description:

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.

Treatment:

Behavioral: EMR Tailoring

GROUP 2:EMR Tailoring+Feedback

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physician Involvement

Behavioral: EMR Tailoring

GROUP 3:EMR+Survey Tailoring alone

Active Comparator group

Description:

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

Treatment:

Behavioral: Survey Tailoring

Behavioral: EMR Tailoring

GROUP 4:EMR+Survey Tailoring+Feedback

Active Comparator group

Description:

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.

Treatment:

Behavioral: Survey Tailoring

Behavioral: Physician Involvement

Behavioral: EMR Tailoring