Feasibility Testing a Decision-support Intervention for Clinical Trials

NCT06291610 | Recruiting DMC

• 1 other identifier: Aarhus University Hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Clinical trial decision making; Patient involvement; Decision coaching; Feasibility study; Complex intervention

Outcome Measures

Primary Outcomes (2)

• Decisional conflict scale

  Measures the level of patients decisional conflict

  The day of signing the clinical trial consent form

• The decision preparation scale

  Measures patients ability to prepare for decision-making

  The day of signing the clinical trial consent form

Secondary Outcomes (2)

• The stages of decision making measure

  The day of signing the clinical trial consent form

• Items on health literacy

  The day of signing the clinical trial consent form

Study Arms (1)

Decision intervention group

OTHER

The decision intervention will be tested in one arm (group)

Behavioral: Clinical trial decision support intervention

Interventions

Clinical trial decision support intervention BEHAVIORAL

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.

Decision intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Dyslexia

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anne W Kristensen, MSc

  Aarhus University Hospital

  STUDY CHAIR

• Cai W Grau, Professor

  Aarhus University Hospital

  STUDY DIRECTOR

• Jeppe Friborg, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Kristensen, MSc

CONTACT

+4530315605; annkrs@rm.dk

Cai Grau, Professor

CONTACT

cai.grau@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients are recruited anonymous
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre- and post-intervention measures in two consecutive groups.

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 4, 2024
• Study Start: February 19, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)