MyelomaNCT02356549
African American Cancer Clinical Trial Decisions: Testing Tailored Messages
A study testing EMR Tailoring, Survey Tailoring and Physician Involvement in people with Myeloma and Lymphoma, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- EMR Tailoring, Survey Tailoring and Physician Involvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Being tested
- EMR Tailoring, Survey Tailoring, Physician Involvement
- Medical subject headings
- Neoplasms, Plasma Cell, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMR TailoringBehavioural
Also called "shallow" level of tailored messages, EMR, Electronic Medical Records (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 TailoringBehavioural
Also called "deeper" level of tailored messages, Tailoring Survey, deep tailoring, Survey data 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 InvolvementBehavioural
Also called Feedback
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: EMR Tailoring |
| 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. Receives: Behavioral: EMR Tailoring; Behavioral: Physician Involvement |
| 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 Receives: Behavioral: EMR Tailoring; Behavioral: Survey Tailoring |
| 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. Receives: Behavioral: EMR Tailoring; Behavioral: Survey Tailoring; Behavioral: Physician Involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study start1 May 2015
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard Brown, Ph.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356549
- Sponsor's protocol ID
- MCC-14-10762
- Other IDs
- HM20002965, NCI-2015-01819
- Status last verified
- Mar 2020
- First submitted
- 15 Jan 2015
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27986738
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African American Cancer Clinical Trial Decisions: Testing Tailored Messages
- ClinicalTrials.gov ID
- NCT02356549
- Acronym / sponsor ID
- MCC-14-10762
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 1 May 2015 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP 1: (EMR) Tailoring Alone | Active comparator | Behavioral: EMR TailoringPatients 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. |
| GROUP 2:EMR Tailoring+Feedback | Active comparator | Behavioral: EMR Tailoring, Behavioral: Physician InvolvementPatients 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. |
| GROUP 3:EMR+Survey Tailoring alone | Active comparator | Behavioral: EMR Tailoring, Behavioral: Survey TailoringPatients 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 |
| GROUP 4:EMR+Survey Tailoring+Feedback | Active comparator | Behavioral: EMR Tailoring, Behavioral: Survey Tailoring, Behavioral: Physician InvolvementPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMR TailoringAlso: "shallow" level of tailored messages, EMR, Electronic Medical Records (EMR) TailoringElectronic Medical Records (EMR) data alone will be entered into the Michigan Tailoring System (MTS system) and their brochures will be prepared. | Behavioural | GROUP 1: (EMR) Tailoring Alone, GROUP 2:EMR Tailoring+Feedback, GROUP 3:EMR+Survey Tailoring alone, GROUP 4:EMR+Survey Tailoring+Feedback |
| Survey TailoringAlso: "deeper" level of tailored messages, Tailoring Survey, deep tailoring, Survey data tailoringSurvey 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. | Behavioural | GROUP 3:EMR+Survey Tailoring alone, GROUP 4:EMR+Survey Tailoring+Feedback |
| Physician InvolvementAlso: FeedbackPrior 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. | Behavioural | GROUP 2:EMR Tailoring+Feedback, GROUP 4:EMR+Survey Tailoring+Feedback |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Derived from this study: PubMed 27986738Brown 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brown, Ph.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMR Tailoring, Survey Tailoring and Physician Involvement in people with Myeloma and Lymphoma, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the efficacy of the tailored health message intervention to increase patient activation. (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02356549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.