About this trial
The Pap test plays a crucial role in the early detection of cervical cancer. A pilot single-center randomized controlled trial applied the peak-end concept and added a non-painful step at the end of Pap smear screening, aimed to reduce recalled pain. However, there is still no multicenter study investigating the effect of the modified Pap test on cervical cancer screening participation.
The present project is the first multicenter randomized controlled trial to expand the current scope of the peak-end theory into Pap tests and cervical cancer screening participation by adding a non-painful step at the end of Pap smear screening. Our multidisciplinary team (NTUH Pap Study Group) aims to provide innovative, feasible, and low-cost strategies for cervical cancer screening participation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 25 or above
Disqualifiers
Ongoing menstruation
Pregnancy
Incapability of understanding the numeric pain scales
Any active cancer at study entry (defined as cancer diagnosed or treated within the previous 6 months, recurrent, regionally advanced or metastatic cancer)
Trial design
Parallel
Treatments tested in this trial
Modified Pap test
Procedure/SurgeryFor the intervention group receiving the modified Pap test, instead of immediately removing the speculum just after rotating back the speculum, an operator still fixes the speculum in the vagina for 15 seconds.
Treatment groups
Trial outcomes
Primary outcomes
3-year cervical cancer screening participation
Defined as attending a Pap test at any clinic before the end of the 3rd subsequent year following study entry
Secondary outcomes
1-year cervical cancer screening participation
Defined as attending a Pap test at any clinic before the end of the next year following study entry
5-minute recalled pain intensity on a 1-5 numeric scale and a 0-10 visual analog scale
Recalled pain intensity at 5 minutes after the Pap smear test with evaluation by a 1-5 numeric scale and a 0-10 visual analog scale.
3-month recalled pain intensity on a 1-5 numeric scale and a 0-10 visual analog scale
Recalled pain intensity at 3 months after the Pap smear test with evaluation by a 1-5 numeric scale and a 0-10 visual analog scale. To minimize potential propaganda for cervical cancer screening participation, the investigators choose the 3-month interval rather than 6-month or 1-year intervals for long-term pain recollection after Pap tests.
Real time pain during the Pap test using a 1-5 numeric scale
The participants will evaluate and record their pain every five seconds throughout the test with an application on a 1 to 5 numeric scale. The average pain, the maximal pain, and real-time pain at the beginning, first quarter, second quarter, third quarter, and the end of the regular course are compared between the two groups. The investigators will compare the average pain of each group's first and second half of the course's course. For participants receiving the modified Pap test, the investigators further compare the average pain, the maximal pain, and the last recorded real-time pain of the 15-second step with that of the regular course.
Other outcomes
Patient-reported feedback at the end of the study
Patient-reported feedback at the health-service level drives revolutions and innovations. At the end of the study period (after the end of the third follow-up year in participants who do not undergo the 3-year cervical cancer screening after the study entry; or at least one month after the latest Pap test in participants who undergo the 3-year cervical cancer screening after the study entry), all participants will be asked to provide open-ended feedback for future qualitative research on Pap smear screening (detailed in subsequent research proposals). For instance, "Can you tell me more about your thoughts on Pap tests you have undergone these years?" or "What is your opinion on the future of Pap tests?".
Sponsors and contacts
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National Taiwan University Hospital
Lead sponsor
National Taiwan University Hospital Hsin-Chu Branch
Collaborator
National Taiwan University
Collaborator
National Taiwan University Hospital Beihu Branch
Collaborator
National Taiwan University Hospital, Yun-Lin Branch
Collaborator
National Science and Technology Council
Collaborator