Feasibility Testing a Decision-support Intervention for Clinical Trials

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Behavioral: Clinical trial decision support 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.

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Kristensen, MSc; Phone Number: +4530315605; Email: annkrs@rm.dk
• Study Contact Backup: Name: Cai Grau, Professor; Email: cai.grau@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Anne Kristensen; Phone Number: +4530315605; Email: annkrs@rm.dk
    • Contact: Cai Grau; Email: cai.grau@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Decision intervention group; The decision intervention will be tested in one arm (group)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Anne W Kristensen, MSc, Aarhus University Hospital; Study Director: Cai W Grau, Professor, Aarhus University Hospital; Principal Investigator: Jeppe Friborg, MD, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Feasibility study; Complex intervention; Patient involvement; Clinical trial decision making; Decision coaching
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Aarhus University Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No