Awareness Enhancing Interventions

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Increasing Recruitment of Underrepresented Cancer Survivors With Awareness Enhancing Interventions

Conditions
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Research Awareness

Intervention / Treatment
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* Other: Navigation - Study Specific - Researcher Voice
* Other: Navigation - Study Specific - Cancer Survivor Voice
* Other: Navigation - Research General - Researcher Voice
* Other: Navigation - Research General - Cancer Survivor Voice
* Other: Brochure - Study Specific - Researcher Voice
* Other: Brochure - Study Specific - Cancer Survivor Voice
* Other: Brochure - Research General - Researcher Voice
* Other: Brochure - Research General - Cancer Survivor Voice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American/Black adults (age ≥50 years old) diagnosed with obesity/physical activity associated cancers that have a 70% or greater 5-year relative cancer-free survival rate multiple myeloma, localized kidney cancer and loco- regional cancers of the colorectum, female breast, prostate, endometrium, and ovary). 1-5 years post diagnosis reside in an area with wireless coverage In the AMPLIFI recruitment pool

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>This group will receive no intervention before receiving the AMPLIFI Recruitment Call | |
| Other: Navigation<br>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. | Other: Navigation - Study Specific - Researcher Voice<br>* The intervention is delivered over the telephone<br>Other: Navigation - Study Specific - Cancer Survivor Voice<br>* The intervention is delivered over the telephone<br>Other: Navigation - Research General - Researcher Voice<br>* The intervention is delivered over the telephone<br>Other: Navigation - Research General - Cancer Survivor Voice<br>* The intervention is delivered over the telephone<br>|
| Other: Brochure<br>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. | Other: Brochure - Study Specific - Researcher Voice<br>* The invention is mailed to the participant in a brochure.<br>Other: Brochure - Study Specific - Cancer Survivor Voice<br>* The invention is mailed to the participant in a brochure.<br>Other: Brochure - Research General - Researcher Voice<br>* The invention is mailed to the participant in a brochure.<br>Other: Brochure - Research General - Cancer Survivor Voice<br>* The invention is mailed to the participant in a brochure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest in Participating in the AMPLIFI Study | proportion of survivors who express interest in participating and return the consent form to the AMPLIFI team. | within 3 months of receiving intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivors, African American, Awareness