African American Cancer Clinical Trial Decisions: Testing Tailored Messages

Lymphoma Clinical Trial

Official title:

African American Cancer Clinical Trial Decisions: Testing Tailored Messages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356549
• Other study ID #: MCC-14-10762
• Secondary ID: HM20002965NCI-20
• Status: Completed
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: March 6, 2020

Study information

• Verified date: March 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Myeloma

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate the efficacy of the tailored health message intervention to increase patient activation.	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.	40 days