Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
4451 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-04-12
Study Completion Date
2025-03-31
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
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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.
Conditions
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Research Awareness
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Control Group
This group will receive no intervention before receiving the AMPLIFI Recruitment Call
Group Type
NO_INTERVENTION
No interventions assigned to this group
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.
Group Type
OTHER
Navigation - Study Specific - Researcher Voice
Intervention Type
OTHER
The intervention is delivered over the telephone
Navigation - Study Specific - Cancer Survivor Voice
Intervention Type
OTHER
The intervention is delivered over the telephone
Navigation - Research General - Researcher Voice
Intervention Type
OTHER
The intervention is delivered over the telephone
Navigation - Research General - Cancer Survivor Voice
Intervention Type
OTHER
The intervention is delivered over the telephone
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.
Group Type
OTHER
Brochure - Study Specific - Researcher Voice
Intervention Type
OTHER
The invention is mailed to the participant in a brochure.
Brochure - Study Specific - Cancer Survivor Voice
Intervention Type
OTHER
The invention is mailed to the participant in a brochure.
Brochure - Research General - Researcher Voice
Intervention Type
OTHER
The invention is mailed to the participant in a brochure.
Brochure - Research General - Cancer Survivor Voice
Intervention Type
OTHER
The invention is mailed to the participant in a brochure.
Interventions
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Navigation - Study Specific - Researcher Voice
The intervention is delivered over the telephone
Intervention Type
OTHER
Navigation - Study Specific - Cancer Survivor Voice
The intervention is delivered over the telephone
Intervention Type
OTHER
Navigation - Research General - Researcher Voice
The intervention is delivered over the telephone
Intervention Type
OTHER
Navigation - Research General - Cancer Survivor Voice
The intervention is delivered over the telephone
Intervention Type
OTHER
Brochure - Study Specific - Researcher Voice
The invention is mailed to the participant in a brochure.
Intervention Type
OTHER
Brochure - Study Specific - Cancer Survivor Voice
The invention is mailed to the participant in a brochure.
Intervention Type
OTHER
Brochure - Research General - Researcher Voice
The invention is mailed to the participant in a brochure.
Intervention Type
OTHER
Brochure - Research General - Cancer Survivor Voice
The invention is mailed to the participant in a brochure.
Intervention Type
OTHER
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
* 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
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
University of Alabama at Birmingham
OTHER
Sponsor Role
collaborator
University of Tennessee
OTHER
Sponsor Role
lead
Responsible Party
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MICHELLE Y MARTIN
Director: Center for Innovation in Health Equity Research
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Michelle Y Marttin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Maria Pisu, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Site Status
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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300002068-B
Identifier Type: -
Identifier Source: org_study_id
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