Research Awareness
Conditions
Keywords
Cancer Survivors, African American, Awareness
Brief summary
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
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.
Interventions
OTHERNavigation - Study Specific - Researcher Voice
The intervention is delivered over the telephone
OTHERNavigation - Study Specific - Cancer Survivor Voice
The intervention is delivered over the telephone
OTHERNavigation - Research General - Researcher Voice
The intervention is delivered over the telephone
OTHERNavigation - Research General - Cancer Survivor Voice
The intervention is delivered over the telephone
OTHERBrochure - Study Specific - Researcher Voice
The invention is mailed to the participant in a brochure.
OTHERBrochure - Study Specific - Cancer Survivor Voice
The invention is mailed to the participant in a brochure.
OTHERBrochure - Research General - Researcher Voice
The invention is mailed to the participant in a brochure.
OTHERBrochure - Research General - Cancer Survivor Voice
The invention is mailed to the participant in a brochure.
Sponsors
National Cancer Institute (NCI)
University of Alabama at Birmingham
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Yield | within 3 months of receiving intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Reference group N=905 | 905 |
| Navigation Phone calls done by Research Educator N=1746 | 1,746 |
| Brochure Education through sending brochures to study participants N=1800 | 1,800 |
| Total | 4,451 |
Baseline characteristics
| Characteristic | Control | Navigation | Brochure | Total |
|---|---|---|---|---|
| Age, Continuous | 65.94 years STANDARD_DEVIATION 8.76 | 65.35 years STANDARD_DEVIATION 8.62 | 65.78 years STANDARD_DEVIATION 8.72 | 65.64 years STANDARD_DEVIATION 8.69 |
| Age, Customized 50 to 65 years | 405 Participants | 842 Participants | 839 Participants | 2086 Participants |
| Age, Customized 65 years plus | 500 Participants | 907 Participants | 958 Participants | 2365 Participants |
| Race/Ethnicity, Customized African Americans | 905 Participants | 1746 Participants | 1800 Participants | 4451 Participants |
| Sex: Female, Male Female | 520 Participants | 1028 Participants | 1025 Participants | 2573 Participants |
| Sex: Female, Male Male | 385 Participants | 718 Participants | 775 Participants | 1878 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: within 3 months of receiving intervention
Population: Number of participants analyzed is equal to survivors eligible for the AMPLIFI trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Recruitment Yield | 13 participants |
| Navigation | Recruitment Yield | 33 participants |
| Brochure | Recruitment Yield | 37 participants |
p-value: 0.234595% CI: [0.724, 3.746]Regression, Logistic
p-value: 0.12495% CI: [0.839, 4.291]Regression, Logistic
Post Hoc
Screened
Proportion of survivors reached by a recruiter who were screened for eligibility
Time frame: within 3 months of the AWEI intervention
Population: Survivors reached by the recruiter
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Screened | 100 Participants |
| Navigation | Screened | 208 Participants |
| Brochure | Screened | 218 Participants |
p-value: 0.165395% CI: [0.921, 1.615]Regression, Logistic
p-value: 0.18195% CI: [0.914, 1.609]Regression, Logistic
Post Hoc
Survivors Reached by Recruiter
Proportion of targeted survivors who were reached by phone by an AMPLIFI study recruiter
Time frame: within 3 months of the AWEI intervention
Population: All randomized
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Survivors Reached by Recruiter | 363 Participants |
| Navigation | Survivors Reached by Recruiter | 659 Participants |
| Brochure | Survivors Reached by Recruiter | 688 Participants |
p-value: 0.235295% CI: [0.768, 1.067]Regression, Logistic
p-value: 0.341895% CI: [0.785, 1.088]Regression, Logistic