Trial Outcomes & Findings for U01 CRC Project for Vietnamese Americans (NCT NCT03413605)
NCT ID: NCT03413605
Last Updated: 2023-08-14
Results Overview
percentage of subjects, who received colorectal screening at 12-month Follow Up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
801 participants
Primary outcome timeframe
12 months
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
a Multilevel CBPR Intervention
The intervention was delivered in group-based education workshop format. The education session was a curriculum-based group education; each group had about 15-20 participants. We allowed 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education had two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session was aimed to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials.
|
Control Group
the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) was provided to control groups.
|
|---|---|---|
|
Overall Study Baseline
STARTED
|
392
|
409
|
|
Overall Study Baseline
COMPLETED
|
392
|
409
|
|
Overall Study Baseline
NOT COMPLETED
|
0
|
0
|
|
Post Intervention Assessment
STARTED
|
392
|
409
|
|
Post Intervention Assessment
COMPLETED
|
392
|
409
|
|
Post Intervention Assessment
NOT COMPLETED
|
0
|
0
|
|
12-m Follow up
STARTED
|
392
|
409
|
|
12-m Follow up
COMPLETED
|
364
|
382
|
|
12-m Follow up
NOT COMPLETED
|
28
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
a Multilevel CBPR Intervention
n=392 Participants
The intervention was delivered in group-based education workshop format. The education session was a curriculum-based group education; each group had about 15-20 participants. We allowed 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education had two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session was aimed to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials.
|
Control Group
n=409 Participants
the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) was provided to control groups.
|
Total
n=801 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-74 years old
|
325 Participants
n=392 Participants
|
321 Participants
n=409 Participants
|
646 Participants
n=801 Participants
|
|
Age, Customized
75 or older
|
67 Participants
n=392 Participants
|
88 Participants
n=409 Participants
|
155 Participants
n=801 Participants
|
|
Sex: Female, Male
Female
|
222 Participants
n=392 Participants
|
252 Participants
n=409 Participants
|
474 Participants
n=801 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=392 Participants
|
157 Participants
n=409 Participants
|
327 Participants
n=801 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Nativity Status
Foreign Born
|
384 Participants
n=386 Participants • n=13 participants did not report their nativity status.
|
399 Participants
n=402 Participants • n=13 participants did not report their nativity status.
|
783 Participants
n=788 Participants • n=13 participants did not report their nativity status.
|
|
Nativity Status
US Born
|
2 Participants
n=386 Participants • n=13 participants did not report their nativity status.
|
3 Participants
n=402 Participants • n=13 participants did not report their nativity status.
|
5 Participants
n=788 Participants • n=13 participants did not report their nativity status.
|
PRIMARY outcome
Timeframe: 12 monthspercentage of subjects, who received colorectal screening at 12-month Follow Up
Outcome measures
| Measure |
a Multilevel CBPR Intervention
n=364 Participants
The intervention was delivered in group-based education workshop format. The education session was a curriculum-based group education; each group had about 15-20 participants. We allowed 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education had two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session was aimed to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials.
|
Control Group
n=382 Participants
the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) was provided to control groups.
|
|---|---|---|
|
Colorectal Cancer Screening Rate
|
333 Participants
|
162 Participants
|
Adverse Events
a Multilevel CBPR Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Dr. Grace X. Ma
Center for Asian Health, Lewis Katz School of Medicine, TempleUniversity
Phone: 215-707-6493
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place