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Feasibility Testing a Decision-support Intervention for Clinical Trials

NCT06291610 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-04

No results posted yet for this 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.

Conditions

  • Head and Neck Neoplasms

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Anne W Kristensen, MSc · Aarhus University Hospital

  • Cai W Grau, Professor · Aarhus University Hospital

  • Jeppe Friborg, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06291610 on ClinicalTrials.gov