Feasibility Testing a Decision-support Intervention for Clinical Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Decisional conflict scale
Study Overview
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.
Detailed Description
Decision-support interventions for patients considering clinical trial participation may promote informed decisions. However, decision interventions for people considering clinical trial participation are still limited.
This study aims to develop and test the acceptability and feasibility of a decision-support intervention to enhance informed decision-making regarding clinical trial participation.
A decision-support intervention has been 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Patients are recruited anonymous
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- Not provided
Arms & Interventions
Decision intervention group
The decision intervention will be tested in one arm (group)
Intervention: Clinical trial decision support intervention (Behavioral)
Outcomes
Primary Outcomes
Decisional conflict scale
Time Frame: The day of signing the clinical trial consent form
Measures the level of patients decisional conflict
The decision preparation scale
Time Frame: The day of signing the clinical trial consent form
Measures patients ability to prepare for decision-making
Secondary Outcomes
- Items on health literacy(The day of signing the clinical trial consent form)
- The stages of decision making measure(The day of signing the clinical trial consent form)