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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA242737-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Alabama at Birmingham | OTHER |
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The purpose of this study is to determine if increasing awareness and, thus, enhancing positive attitudes about research, prior to recruitment attempts, will increase participation in cancer clinical research among African American (AA) cancer survivors so that recruitment efforts can focus on the most optimal and cost- effective approaches
In this project, 2000 AA potential AMPLIFI project participants will be randomized to the awareness-enhancing intervention (AWEI) or to the comparison condition in which they do not receive AWEI intervention but only the Adapting Multiple Behavior Interventions that Effectively Improve Cancer Survivor Health (AMPLIFI) basic recruitment strategy (No AWEI). Randomization for the AWEI Randomized Controlled Trial (RCT) will occur soon after the AMPLIFI recruitment letter is sent, and AWEI interventions will be delivered over a two-week period between the AMPLIFI recruitment invitation letter and the AMPLIFI recruitment call. Survivors randomized to AWEI intervention will be exposed to 8 different combinations of the AWEI components according to different types of strategies and type of information reflecting the survivor voice or not. Subsequent to the AMPLIFI recruitment call, a 20% random sample of cancer survivors will be surveyed over the phone to assess intervention fidelity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | This group will receive no intervention before receiving the AMPLIFI Recruitment Call | |
| Navigation | Other | After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a phone call from a Research Specialist who will discuss the importance of research participation for cancer survivors to increase research awareness and aid in recruitment. The information will focus on the importance of research and will be delivered from the perspective of either a researcher or a cancer survivor. |
|
| Brochure | Other | After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a brochure which will focus on the importance of research participation for cancer survivors in order to increase research awareness and aid in recruitment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation - Study Specific - Researcher Voice | Other | The intervention is delivered over the telephone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Yield | measured by the proportion of targeted survivors who, at the time of the recruitment call, after the screening process is complete, decide to participate in AMPLIFI. | within 3 months of receiving intervention |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Y Marttin, PhD | University of Tennessee | Principal Investigator |
| Maria Pisu, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Tennessee Health Science Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26801772 | Background | Bester N, Di Vito-Smith M, McGarry T, Riffkin M, Kaehler S, Pilot R, Bwire R. The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals. Adv Ther. 2016 Feb;33(2):167-77. doi: 10.1007/s12325-016-0284-y. Epub 2016 Jan 23. | |
| 16215867 | Background | Beskow LM, Sandler RS, Millikan RC, Weinberger M. Patient perspectives on research recruitment through cancer registries. Cancer Causes Control. 2005 Dec;16(10):1171-5. doi: 10.1007/s10552-005-0407-2. |
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We will share data which will include the AMPLIFI final disposition code (recruited versus not recruited), the impact of the AWEI interventions versus the standard recruitment approach.
All data will be shared once all primary outcomes papers have been published (consonant with the NIH definition of "timely fashion") but no later than within one year of the completion of the funded study.
The access to the data will be granted to investigators working in an organization with a Federal Wide Assurance (FWA). Before access is granted, individuals must provide a copy of their Institutional Review Board (IRB) approval to use the data to answer their specific study questions. Individuals in receipt of data must produce proof of human subjects and HIPAA training. All datasets will conform to the "Standards for Privacy of Individually Identifiable Health Information" rule of HIPAA. In order to maintain HIPAA compliance, we will provide a limited-use dataset (i.e., stripped of identifying information). Requesting users will be required to sign a data-use sharing agreement. Although not immediately precluded, data deemed to be "sensitive" will be added to limited use datasets only after careful consideration. Resulting publications must credit the funding for this grant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | This group will receive no intervention before receiving the AMPLIFI Recruitment Call |
| FG001 | Navigation | After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a phone call from a Research Specialist who will discuss the importance of research participation for cancer survivors to increase research awareness and aid in recruitment. The information will focus on the importance of research and will be delivered from the perspective of either a researcher or a cancer survivor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2024 |
Not provided
AMPLIFI recruitment process, 1600 AA cancer survivors will be randomized to one of 8 conditions that vary by type of strategy, type of information, and type of perspective (survivor or researcher "voice") and 400 randomized to the basic recruitment strategy
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| Navigation - Study Specific - Cancer Survivor Voice | Other | The intervention is delivered over the telephone |
|
| Navigation - Research General - Researcher Voice | Other | The intervention is delivered over the telephone |
|
| Navigation - Research General - Cancer Survivor Voice | Other | The intervention is delivered over the telephone |
|
| Brochure - Study Specific - Researcher Voice | Other | The invention is mailed to the participant in a brochure. |
|
| Brochure - Study Specific - Cancer Survivor Voice | Other | The invention is mailed to the participant in a brochure. |
|
| Brochure - Research General - Researcher Voice | Other | The invention is mailed to the participant in a brochure. |
|
| Brochure - Research General - Cancer Survivor Voice | Other | The invention is mailed to the participant in a brochure. |
|
| Memphis |
| Tennessee |
| 38105 |
| United States |
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| FG002 | Brochure | After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a brochure which will focus on the importance of research participation for cancer survivors in order to increase research awareness and aid in recruitment. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Reference group N=905 |
| BG001 | Navigation | Phone calls done by Research Educator N=1746 |
| BG002 | Brochure | Education through sending brochures to study participants N=1800 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Yield | measured by the proportion of targeted survivors who, at the time of the recruitment call, after the screening process is complete, decide to participate in AMPLIFI. | Number of participants analyzed is equal to survivors eligible for the AMPLIFI trial | Posted | Number | participants | within 3 months of receiving intervention |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Survivors Reached by Recruiter | Proportion of targeted survivors who were reached by phone by an AMPLIFI study recruiter | All randomized | Posted | Count of Participants | Participants | within 3 months of the AWEI intervention |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Screened | Proportion of survivors reached by a recruiter who were screened for eligibility | Survivors reached by the recruiter | Posted | Count of Participants | Participants | within 3 months of the AWEI intervention |
|
No adverse events were monitored
Total Number of Participants at Risk (e.g., "All-Cause Mortality, Serious, and Other [Not Including Serious] is 0 because Adverse Events were not monitored/assessed due to the minimal risk interventions tested
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Reference group N=905 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Navigation | Phone calls done by Research Educator N=1746 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Brochure | Education through sending brochures to study participants N=1800 | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principle investigator | University of Tennessee Health Science Center | (901)448-2383 | mmart126@uthsc.edu |
| Mar 31, 2025 |
| Prot_SAP_000.pdf |
| 65 years plus |
|
| Male |
|
| Odds Ratio (OR) |
| 1.897 |
| 2-Sided |
| 95 |
| 0.839 |
| 4.291 |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|