Ameliorated Pap Tests and Cervical Cancer Screening Participation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorNational Taiwan University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Modified Pap test

    Procedure/Surgery

    For 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

248 Participants
are divided into 2 treatment groups
Group A: Traditional Pap testNo intervention 0 interventions
Group B: Modified Pap testExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 years

Secondary outcomes

1

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

Time frame
1 year
2

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.

Time frame
5 minutes after receiving the Pap smear test
3

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.

Time frame
3 months after receiving the Pap smear test
4

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.

Time frame
Every five seconds throughout the Pap test, up to completion of Pap test

Other outcomes

1

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?".

Time frame
At the fourth follow-up year in participants who do not undergo the 3-year cervical cancer screening; or between 1 and 12 months after the latest Pap test in participants who undergo the 3-year cervical cancer screening

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