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Clinical Trials in Denmark / NCT06291610
Recruiting Not applicable

Feasibility Testing a Decision-support Intervention for Clinical Trials

NCT06291610 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Not applicable
Started
2024-02-19
Last updated
2024-03-04

Condition(s) studied

Head and Neck Neoplasms

Investigational drug(s) / intervention(s)

Clinical trial decision support intervention

Clinical trial decision support intervention: 1. a patient decision aid tailored to clinical trial participation 2. decision coaching consultations carried out by trained healthcare professionals. 3. a training program in decision coaching will be an integrated part of the intervention.

Study summary

A decision-support intervention are developed for a Danish nationwide randomised controlled trial (RCT) among patients with laryngeal and pharyngeal cancer referred to curative intended radiotherapy. The primary endpoints in this RCT are levels of dysphagia and xerostomia.

The decision-support intervention consists of three components, including (1) a patient decision aid tailored to clinical trial participation and (2) decision coaching consultations carried out by trained healthcare professionals. Finally, (3) a training program in decision coaching will be an integrated part of the intervention.

To feasibility test (beta test) the intervention, 60 patient participants will be included, separated into pre- (n=30) and post- (n=30) intervention groups. Pre-intervention to complete the survey based on current clinical practice. Post-intervention to complete the survey following engagement in the decision support intervention.

A total of 12 physicians will be recruited and trained in decision coaching. To assess the acceptability of the intervention, the physicians will be interviewed. Additionally, they will be asked to audio-record two decision coaching sessions to test the fidelity of the intervention.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with cancer of the pharynx or larynx * Received verbal information regarding DAHANCA 35 * Read the patient information folder from DAHANCA 35 * Above 18 years * Danish speaking Exclusion Criteria: * Dyslexia

Primary outcome measure(s)

  • Decisional conflict scale — The day of signing the clinical trial consent form
    Measures the level of patients decisional conflict
  • The decision preparation scale — The day of signing the clinical trial consent form
    Measures patients ability to prepare for decision-making

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark Recruiting

More University of Aarhus trials in Denmark

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IMPROVE: Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer Active, not recruiting
Danish Access to Support and Help (DASH): Increasing Access to an Evidence-based Intervention for Children With ADHD and Their Parents Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06291610 on ClinicalTrials.gov ↗ ← All trials in Denmark