Feasibility Testing a Decision-support Intervention for Clinical Trials

Head and Neck Neoplasms Clinical Trial

Official title:

Feasibility Testing a Decision-support Intervention for Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291610
• Other study ID #: Aarhus University Hospital
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: University of Aarhus
• Contact: Anne Kristensen, MSc
• Phone: +4530315605
• Email: annkrs[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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.

Methods:

Patient participants outcome ( questionnaire survey)

1. The stages of decision making measure (self translated forward/backward)

2. Decisional conflict scale

3. The decision preparation scale (post intervention measure)

4. Items on health literacy related to the specific context (understanding the trial, the treatment modalities, practical issues, etc.)

5. Decision preference

The interviews with the clinicians (decision coaches) will follow the interpretive description methodology and be conducted as qualitative, semi-structured audio-recorded interviews. The interviews will be carried out on the telephone.

The quantitative data will be hosted, organised, and analysed in STATA. The qualitative data will be hosted, organised, and analysed in a software system called NVivo.

To evaluate the impact of the decision-support intervention, it is necessary to assess the extent to which it is used as intended in clinical practice. This is referred to as a fidelity test. Hence, the decision coaches will be provided with dictaphones and asked to audio-record the consultations. The audio records will be evaluated using the Decision Support Analysis Tool (DSAT-10), which is a tool to assess practitioners' use of decision support and communication skills during a clinical encounter.

Further studies

Building upon the current study, the potential for further development, implementation and evaluation across proton therapy clinical trials will be determined.

Assessing a decision support intervention for trial participation in a single host trial is challenging due to the limited period of the host trial and insufficient statistical power for comparative tests.

Additional intervention development could involve establishing an online decision support intervention platform for Danish proton therapy clinical trials and a training platform in decision coaching for healthcare professionals. Moreover, integrating measurements (decisional conflict, etc.) as active pro measures to identify decisional needs during decisional coaching could be explored.

A cluster randomised trial is the most suitable approach for full-scale implementation and evaluation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict scale	Measures the level of patients decisional conflict	The day of signing the clinical trial consent form
Primary	The decision preparation scale	Measures patients ability to prepare for decision-making	The day of signing the clinical trial consent form
Secondary	The stages of decision making measure	Measures the stage patients are in during the decision-making process	The day of signing the clinical trial consent form
Secondary	Items on health literacy	Related to the specific context (understanding the trial, the treatment modalities, practical issues, etc.)	The day of signing the clinical trial consent form