Clinical trial NCT02356549: African American Cancer Clinical Trial Decisions: Testing Tailored Messages
Official title: African American Cancer Clinical Trial Decisions: Testing Tailored Messages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myeloma
Lymphoma
Leukemia
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2015-02-05
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Demonstrate the efficacy of the tailored health message intervention to increase patient activation.
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Richard Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown RF, Davis R, Wilson Genderson M, Grant S, Cadet D, Lessard M, Alpert J, Ward J, Ginder G. African-American patients with cancer Talking About Clinical Trials (TACT) with oncologists during consultations: evaluating the efficacy of tailored health messages in a randomised controlled trial-the TACT study protocol. BMJ Open. 2016 Dec 16;6(12):e012864. doi: 10.1136/bmjopen-2016-012864.