Trial Outcomes & Findings for St. Joe's Invitation Effectiveness Study (NCT NCT04658888)
NCT ID: NCT04658888
Last Updated: 2022-07-06
Results Overview
To compare the percentage of cervical cancer screenings completed in the control group who received a standard letter with the percentage of cervical cancer screenings completed in the intervention group who receive a modified letter with a self-sampling option.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
964 participants
Primary outcome timeframe
Three months after the letter is sent.
Results posted on
2022-07-06
Participant Flow
A report from the electronic medical record identified woman ages 30-65 who were out of date for cervical cancer screening. Letters were sent to the patient's home during June-July 2021.
No participants who qualified were excluded from the study.
Participant milestones
| Measure |
Modified Letter With Self-sampling Request Card
This group received a modified letter telling the participant they are out of date with their cervical cancer screening, received information on the self-sampling kit and postcard to request a kit.
|
Standard Letter
Participants received a standard of care reminder letter telling the participant they are out of date with their cervical cancer screening and to contact their primary care provider to schedule an appointment.
|
|---|---|---|
|
Overall Study
STARTED
|
333
|
631
|
|
Overall Study
COMPLETED
|
333
|
631
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
St. Joe's Invitation Effectiveness Study
Baseline characteristics by cohort
| Measure |
Modified Letter With Self-sampling Request Card
n=333 Participants
This group received a modified letter telling the participant they are out of date with their cervical cancer screening. They also received information on the self-sampling kit and were provided a card that they can send back to the study team in order to have a kit sent to their house. The kit included a pre-paid mailer so that it can be sent back to the lab for testing.
Evalyn Self-Sampling Brush: A self-sampling brush to collect cervical cancer cells for screening purposes.
|
Standard Letter
n=631 Participants
Participants received a standard of care letter that tells the participant they are out of date with their cervical cancer screening and should contact their primary care provider to schedule an appointment.
|
Total
n=964 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-65 years
|
333 participants
n=5 Participants
|
631 participants
n=7 Participants
|
964 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
333 Participants
n=5 Participants
|
631 Participants
n=7 Participants
|
964 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
189 Participants
n=5 Participants
|
359 Participants
n=7 Participants
|
548 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
361 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
46 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
169 Participants
n=5 Participants
|
315 Participants
n=7 Participants
|
484 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
333 participants
n=5 Participants
|
631 participants
n=7 Participants
|
964 participants
n=5 Participants
|
|
Insurance type
private
|
46 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Insurance type
other
|
267 Participants
n=5 Participants
|
512 Participants
n=7 Participants
|
779 Participants
n=5 Participants
|
|
Insurance type
Missing
|
20 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three months after the letter is sent.To compare the percentage of cervical cancer screenings completed in the control group who received a standard letter with the percentage of cervical cancer screenings completed in the intervention group who receive a modified letter with a self-sampling option.
Outcome measures
| Measure |
Modified Letter With Self-sampling Request Card
n=333 Participants
There were 333 participants in this group. This group received a modified letter telling the participant they are out of date with their cervical cancer screening. They also received information on the self-sampling kit and were provided a card that they can send back to the study team in order to have a kit sent to their house. The kit included a pre-paid mailer so that it can be sent back to the lab for testing. The result were then be shared with the participant.
Evalyn Self-Sampling Brush: A self-sampling brush to collect cervical cancer cells for screening purposes.
|
Standard Letter
n=631 Participants
There were 631 participants in this group. Participants received a standard of care letter that tells the participant they are out of date with their cervical cancer screening and should contact their primary care provider to schedule an appointment.
|
|---|---|---|
|
Percentage of Cervical Cancer Screening
|
40 Participants
|
95 Participants
|
PRIMARY outcome
Timeframe: Three months after the letter is sentEvaluate the number of participants request and use the self-sampling kit in the intervention group.
Outcome measures
| Measure |
Modified Letter With Self-sampling Request Card
n=333 Participants
There were 333 participants in this group. This group received a modified letter telling the participant they are out of date with their cervical cancer screening. They also received information on the self-sampling kit and were provided a card that they can send back to the study team in order to have a kit sent to their house. The kit included a pre-paid mailer so that it can be sent back to the lab for testing. The result were then be shared with the participant.
Evalyn Self-Sampling Brush: A self-sampling brush to collect cervical cancer cells for screening purposes.
|
Standard Letter
There were 631 participants in this group. Participants received a standard of care letter that tells the participant they are out of date with their cervical cancer screening and should contact their primary care provider to schedule an appointment.
|
|---|---|---|
|
Use of the Self-sampling Kit
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Three months after the letter is sentOverall rate of cervical cancer screenings for both the control group and the intervention group.
Outcome measures
| Measure |
Modified Letter With Self-sampling Request Card
n=964 Participants
There were 333 participants in this group. This group received a modified letter telling the participant they are out of date with their cervical cancer screening. They also received information on the self-sampling kit and were provided a card that they can send back to the study team in order to have a kit sent to their house. The kit included a pre-paid mailer so that it can be sent back to the lab for testing. The result were then be shared with the participant.
Evalyn Self-Sampling Brush: A self-sampling brush to collect cervical cancer cells for screening purposes.
|
Standard Letter
There were 631 participants in this group. Participants received a standard of care letter that tells the participant they are out of date with their cervical cancer screening and should contact their primary care provider to schedule an appointment.
|
|---|---|---|
|
Overall Rate of Cervical Cancer Screening Over Both the Control and Intervention Group
|
135 Participants
|
—
|
Adverse Events
Modified Letter With Self-sampling Request Card
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Letter
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. Christina Scartozzi
Penn State Health Milton S Hershey Medical Center
Phone: 484-650-0885
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place