Clinical trial NCT06291610: Feasibility Testing a Decision-support Intervention for Clinical Trials
Official title: Feasibility Testing a Decision-support Intervention for Clinical Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: Clinical trial decision making
Patient involvement
Decision coaching
Feasibility study
Complex intervention
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre- and post-intervention measures in two consecutive groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decisional conflict scale
timeFrame: The day of signing the clinical trial consent form
measure: The decision preparation scale
timeFrame: The day of signing the clinical trial consent form
Secondary outcomes:
measure: The stages of decision making measure
timeFrame: The day of signing the clinical trial consent form
measure: Items on health literacy
timeFrame: The day of signing the clinical trial consent form
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Anne W Kristensen, MSc
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Cai W Grau, Professor
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Jeppe Friborg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: