ClinicalTrials.gov
ClinicalTrials.gov Menu

African American Cancer Clinical Trial Decisions: Testing Tailored Messages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02356549
Recruitment Status : Recruiting
First Posted : February 5, 2015
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myeloma Lymphoma Leukemia Behavioral: EMR Tailoring Behavioral: Survey Tailoring Behavioral: Physician Involvement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 948 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: African American Cancer Clinical Trial Decisions: Testing Tailored Messages
Study Start Date : May 1, 2015
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GROUP 1: (EMR) Tailoring Alone
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.
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.
Other Names:
  • "shallow" level of tailored messages
  • EMR
  • Electronic Medical Records (EMR) Tailoring

Active Comparator: GROUP 2:EMR Tailoring+Feedback
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.
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.
Other Names:
  • "shallow" level of tailored messages
  • EMR
  • Electronic Medical Records (EMR) Tailoring

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.
Other Name: Feedback

Active Comparator: GROUP 3:EMR+Survey Tailoring alone
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
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.
Other Names:
  • "shallow" level of tailored messages
  • EMR
  • Electronic Medical Records (EMR) Tailoring

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.
Other Names:
  • "deeper" level of tailored messages
  • Tailoring Survey
  • deep tailoring
  • Survey data tailoring

Active Comparator: GROUP 4:EMR+Survey Tailoring+Feedback
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.
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.
Other Names:
  • "shallow" level of tailored messages
  • EMR
  • Electronic Medical Records (EMR) Tailoring

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.
Other Names:
  • "deeper" level of tailored messages
  • Tailoring Survey
  • deep tailoring
  • Survey data tailoring

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.
Other Name: Feedback




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356549


Contacts
Contact: Richard Brown, Ph.D. 804-628-3340 rbrown39@vcu.edu
Contact: Jamesha Ward 804-628-3826 wardjf@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Richard Brown, PhD    804-628-3340    rbrown39@vcu.edu   
Contact: Jamesha Ward    804-628-3826    wardjf@vcu.edu   
Principal Investigator: Richard Brown, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
American Cancer Society, Inc.
Investigators
Principal Investigator: Richard Brown, Ph.D. Virginia Commonwealth University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02356549     History of Changes
Other Study ID Numbers: MCC-14-10762
HM20002965 ( Other Identifier: Virginia Commonwealth University )
NCI-2015-01819 ( Registry Identifier: NCI CTRP )
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No