NCT07146152

Brief Summary

The aim of this stepped-wedge randomized clinical trial is to assess the impact of implementing a patient decision aid during consultations with patients diagnosed with cervical precancer. Specifically, it will evaluate whether the decision aid enhances shared decision-making, improves the patient experience, and influences their treatment preferences. The main questions this study aims to answer are:

  1. 1.Will the implementation of the patient decision aid increase the number of patients with cervical precancer who opt for surgery (loop electrical excision) compared to active surveillance?
  2. 2.Will the implementation of the patient decision aid improve patients' experience with the course of treatment for cervical precancer?

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Oct 2025Apr 2030

First Submitted

Initial submission to the registry

July 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

August 28, 2025

Status Verified

July 1, 2025

Enrollment Period

4.6 years

First QC Date

July 1, 2025

Last Update Submit

August 21, 2025

Conditions

CIN2

Keywords

Shared decision makingCervical precancerCervical intraepithelial neoplasiaShared Decision-makingSDMPatient Decision AidCIN2

Outcome Measures

Primary Outcomes (1)

  • Surgical Intervention vs. Active Surveillance

    A comparison of the number of patients choosing surgical treatment during the study period.

    The treatment decision will be documented immediately after it is made, expected within one month after inclusion.

Secondary Outcomes (7)

  • Decision Regret

    From enrolment until 9 months follow-up.

  • Anxiety levels

    From enrollment until 9 months follow-up.

  • Shared decision making

    Data will be collected from the time of inclusion and within a short period following the treatment decision, typically around 1 month after inclusion.

  • Shared Decision Making

    Data will be collected from the time of inclusion and within a short period following the treatment decision, typically around 1 month after inclusion.

  • Shared Decision Making

    Data will be collected from the time of inclusion and within a short period following the treatment decision, typically around 1 month after inclusion.

  • +2 more secondary outcomes

Study Arms (2)

Control arm

NO INTERVENTION

Patients with CIN2 recieving standard information about treatment choices (Standard of Care)

Intervention Arm

EXPERIMENTAL

Patients with CIN2 receiving information about treatment options using a Patient Decision Aid to promote shared decision making.

Device: Patient Decision Aid

Interventions

Patient Decision AidDEVICE

A Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance.

Intervention Arm

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Newly diagnosed CIN2
  • Age 18-50 years old

You may not qualify if:

  • CIN2 or worse or conization surgery within the last 2 years.
  • Pregnancy
  • Immunosuppressed individuals, including those with HIV and organ transplant recipients
  • Non-visible transformation zone
  • Language difficulties requiring an interpreter or translator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Hospital Gødstrup

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Stepped Wedge Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2025

First Posted

August 28, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2030

Last Updated

August 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)