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| Name | Class |
|---|---|
| Region MidtJylland Denmark | OTHER |
| Gødstrup Hospital | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Decision Aid | Device | A Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Decision Regret | Decision regret will be measured using the validated "Decision Regret Scale", which ranges from 1 (indicating low regret) to 5 (indicating high regret). | From enrolment until 9 months follow-up. |
| Anxiety levels |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Gødstrup | Herning | 7400 | Denmark |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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Stepped Wedge Randomized Controlled Trial
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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.
| From enrollment until 9 months follow-up. |
| Shared decision making | 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). | 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 | The degree of shared decision-making will be assessed from the participants' point of view using the validated questionnaire "Shared Decision-Making Process-4". | 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 | The extent of shared decision-making will be assessed from the participants' point of view using the validated questionnaire "Shared Decision Making Questionnaire Q9 (SDM-Q-9). | 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 from the doctor's point of view. | 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". | Data will be collected at a single time point, immediately following the consultation in which the treatment decision is made. |
| Decisional conflict | 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). | 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. |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |