CIN2
Conditions
Keywords
Shared decision making, Cervical precancer, Cervical intraepithelial neoplasia, Shared Decision-making, SDM, Patient Decision Aid, CIN2
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. 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. Will the implementation of the patient decision aid improve patients' experience with the course of treatment for cervical precancer? To evaluate this, researchers will compare patients receiving counseling with the support of the decision aid to those receiving standard counseling without the decision aid. After the consultation, participants will complete questionnaires to share their experience. Data on treatment choices will be gathered from patient medical records.
Interventions
DEVICEPatient Decision Aid
A Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance.
Sponsors
Region MidtJylland Denmark
Gødstrup Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Stepped Wedge Randomized Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed CIN2 * Age 18-50 years old
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Intervention vs. Active Surveillance | The treatment decision will be documented immediately after it is made, expected within one month after inclusion. | A comparison of the number of patients choosing surgical treatment during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety levels | From enrollment until 9 months follow-up. | Participants' anxiety levels will be measured both before and after they make a decision regarding their treatment. The validated State-Trait Anxiety Inventory (STAI) will be used, which rates anxiety on a scale from 1 to 4, with 4 indicating the highest level of anxiety. |
| 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. | Measurement of degree of shared decision-making from the participants' point of view using validated questionnaire CollaboRATE. Patients report to which degree they felt the doctor fascilitated shared decision-making during the consultation. The scale ranges from 1 (to the lowest degree) to 9 (to the highest degree). |
| Decision Regret | From enrolment until 9 months follow-up. | Decision regret will be measured using the validated Decision Regret Scale, which ranges from 1 (indicating low regret) to 5 (indicating high regret). |
| Shared Decision Making from the doctor's point of view. | Data will be collected at a single time point, immediately following the consultation in which the treatment decision is made. | The degree of shared decision-making will be assessed from the physician's point of view using the validated questionnaire Shared Decision Making Questionnaire - Physician Version. |
| Decisional conflict | The questionnaire is administered at two time points: prior to the consultation regarding treatment choice, and immediately after the consultation. Data collection is expected to be completed within one month of enrollment. | Measurement of decisional conflict using the validated questionnaire Decisional Conflict Scale. The scale ranges from 1 (low degree of decisional conflict) to 5 (high degree of decisional conflict). |
| 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. | The degree of shared decision-making will be assessed from the participants' point of view using the validated questionnaire Shared Decision-Making Process-4. |
Countries
Denmark
Outcome results
None listed