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NCT06291610

Feasibility Testing a Decision-support Intervention for Clinical Trials

Recruiting now NA Last updated 4 March 2024
What this trial tests

NA trial testing Clinical trial decision support intervention in Head and Neck Neoplasms in 60 participants. Currently enrolling.

Timeline
19 February 2024
Primary endpoint
31 December 2025
31 December 2026

Quick facts

Lead sponsorUniversity of Aarhus
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment60
Start date19 February 2024
Primary completion31 December 2025
Estimated completion31 December 2026
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Head and Neck Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Development of a Patient Decision Aid for the DAHANCA 35 Proton Radiotherapy Trial: An Iterative Development Process with User-Centered Design Elements.
    Kristensen AW, Jensen AL, Jensen K, Dalton SO, et al · · 2026 · PMID 42110365 · DOI 10.1177/23814683261441513

Verify or expand the search:

Other recruiting trials for Head and Neck Neoplasms

Currently open trials in the same condition.

Other University of Aarhus trials

Trials by the same sponsor.

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Data sources for this page

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