Ameliorated Pap Tests and Cervical Cancer Screening Participation

NCT06968871 | Recruiting

• 1 other identifier: 202502041RINE
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Cervical Cancer Screening; Cervical Cancer Screening Methods

Keywords

Cancer screening participation; Cervical cancer; Multicenter; Multidisciplinary; Pain; Pap smear; Peak-end concept; Preventive medicine; Randomized controlled trial

Outcome Measures

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

  3 years

Secondary Outcomes (4)

• 1-year cervical cancer screening participation

  1 year

• 5-minute recalled pain intensity on a 1-5 numeric scale and a 0-10 visual analog scale

  5 minutes after receiving the Pap smear test

• 3-month recalled pain intensity on a 1-5 numeric scale and a 0-10 visual analog scale

  3 months after receiving the Pap smear test

• Real time pain during the Pap test using a 1-5 numeric scale

  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

  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

Study Arms (2)

Traditional Pap test

NO INTERVENTION

Modified Pap test

EXPERIMENTAL

Procedure: Modified Pap test

Interventions

Modified Pap test PROCEDURE

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.

Modified Pap test

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 25 or above

You may not qualify if:

• 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)
• Previous hysterectomy, pelvic surgery, or radiotherapy
• Active vaginal or uterus infection
• Analgesic use within 24 hours

Sponsors & Collaborators

• 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
• National Taiwan University Hospital: lead
• National Taiwan University Hospital Hsin-Chu Branch: collaborator

Study Sites (5)

National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

RECRUITING

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital Beihu Branch

Taipei, Taiwan

RECRUITING

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MeSH Terms

Conditions

Uterine Cervical Neoplasms; Pain

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chien-Hsieh Chiang, MD, MPH, PhD

  National Taiwan University Hospital & College of Medicine

  STUDY CHAIR

Central Study Contacts

Chien-Hsieh Chiang, MD, MPH, PhD

CONTACT

886 + 972651864; jiansie@gmail.com

Yu-Chung Wu, MD

CONTACT

jiansie@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Cytopathologists who analyze the specimens are blinded to the study.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 13, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)