Trial Outcomes & Findings for Awareness Enhancing Interventions (NCT NCT04683510)
NCT ID: NCT04683510
Last Updated: 2025-05-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4451 participants
Primary outcome timeframe
within 3 months of receiving intervention
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Control Group
This group will receive no intervention before receiving the AMPLIFI Recruitment Call
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
905
|
1746
|
1800
|
|
Overall Study
COMPLETED
|
905
|
1746
|
1800
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Awareness Enhancing Interventions
Baseline characteristics by cohort
| Measure |
Control
n=905 Participants
Reference group N=905
|
Navigation
n=1746 Participants
Phone calls done by Research Educator N=1746
|
Brochure
n=1800 Participants
Education through sending brochures to study participants N=1800
|
Total
n=4451 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.94 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
65.35 years
STANDARD_DEVIATION 8.62 • n=7 Participants
|
65.78 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
65.64 years
STANDARD_DEVIATION 8.69 • n=4 Participants
|
|
Age, Customized
50 to 65 years
|
405 Participants
n=5 Participants
|
842 Participants
n=7 Participants
|
839 Participants
n=5 Participants
|
2086 Participants
n=4 Participants
|
|
Age, Customized
65 years plus
|
500 Participants
n=5 Participants
|
907 Participants
n=7 Participants
|
958 Participants
n=5 Participants
|
2365 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
520 Participants
n=5 Participants
|
1028 Participants
n=7 Participants
|
1025 Participants
n=5 Participants
|
2573 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
385 Participants
n=5 Participants
|
718 Participants
n=7 Participants
|
775 Participants
n=5 Participants
|
1878 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African Americans
|
905 Participants
n=5 Participants
|
1746 Participants
n=7 Participants
|
1800 Participants
n=5 Participants
|
4451 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 3 months of receiving interventionPopulation: Number of participants analyzed is equal to survivors eligible for the AMPLIFI trial
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.
Outcome measures
| Measure |
Control
n=37 Participants
Reference group N=905
|
Navigation
n=70 Participants
Phone calls done by Research Educator N=1746
|
Brochure
n=73 Participants
Education through sending brochures to study participants N=1800
|
|---|---|---|---|
|
Recruitment Yield
|
13 participants
|
33 participants
|
37 participants
|
POST_HOC outcome
Timeframe: within 3 months of the AWEI interventionPopulation: All randomized
Proportion of targeted survivors who were reached by phone by an AMPLIFI study recruiter
Outcome measures
| Measure |
Control
n=905 Participants
Reference group N=905
|
Navigation
n=1746 Participants
Phone calls done by Research Educator N=1746
|
Brochure
n=1800 Participants
Education through sending brochures to study participants N=1800
|
|---|---|---|---|
|
Survivors Reached by Recruiter
|
363 Participants
|
659 Participants
|
688 Participants
|
POST_HOC outcome
Timeframe: within 3 months of the AWEI interventionPopulation: Survivors reached by the recruiter
Proportion of survivors reached by a recruiter who were screened for eligibility
Outcome measures
| Measure |
Control
n=363 Participants
Reference group N=905
|
Navigation
n=659 Participants
Phone calls done by Research Educator N=1746
|
Brochure
n=688 Participants
Education through sending brochures to study participants N=1800
|
|---|---|---|---|
|
Screened
|
100 Participants
|
208 Participants
|
218 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brochure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principle investigator
University of Tennessee Health Science Center
Phone: (901)448-2383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place