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| ID | Type | Description | Link |
|---|---|---|---|
| HM20002965 | Other Identifier | Virginia Commonwealth University | |
| NCI-2015-01819 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP 1: (EMR) Tailoring Alone | Active Comparator | 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. |
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| GROUP 2:EMR Tailoring+Feedback | Active Comparator | 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. |
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| GROUP 3:EMR+Survey Tailoring alone | Active Comparator | 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 |
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| GROUP 4:EMR+Survey Tailoring+Feedback | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusions Criteria:
-None
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| Name | Affiliation | Role |
|---|---|---|
| Richard Brown, Ph.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27986738 | Derived | 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. |
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| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D057286 | Electronic Health Records |
| ID | Term |
|---|---|
| D016347 | Medical Records Systems, Computerized |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
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| 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. |
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| 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. |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |