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Completed

NCT Number: NCT02356549

African American Cancer Clinical Trial Decisions: Testing Tailored Messages

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.

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Key information

Conditions

Myeloma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMR Tailoring

Behavioral

Electronic Medical Records (EMR) data alone will be entered into the Michigan Tailoring System (MTS system) and their brochures will be prepared.

Other names: "shallow" level of tailored messages, EMR, Electronic Medical Records (EMR) Tailoring

Survey Tailoring

Behavioral

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.

Other names: "deeper" level of tailored messages, Tailoring Survey, deep tailoring, Survey data tailoring

Physician Involvement

Behavioral

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.

Other names: Feedback

Primary outcomes

  1. Demonstrate the efficacy of the tailored health message intervention to increase patient activation.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2015
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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