Head and Neck NeoplasmsNCT06291610
Feasibility Testing a Decision-support Intervention for Clinical Trials
A study testing Clinical trial decision support intervention in people with Head and Neck Neoplasms, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Clinical trial decision support intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dyslexia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cai Grau, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Anne Kristensen, +4530315605, annkrs@rm.dk
Cai Grau, cai.grau@rm.dk
About this study
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.
Read more
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.
Read the 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)
- The stages of decision making measure (self translated forward/backward)
- Decisional conflict scale
- The decision preparation scale (post intervention measure)
- Items on health literacy related to the specific context (understanding the trial, the treatment modalities, practical issues, etc.)
- 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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Clinical trial decision support intervention
- Keywords
- Clinical trial decision making, Patient involvement, Decision coaching, Feasibility study, Complex intervention
- Medical subject headings
- Head and Neck Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical trial decision support interventionBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Decision intervention group | Other | The decision intervention will be tested in one arm (group) Receives: Behavioral: Clinical trial decision support intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict scale
Measures the level of patients decisional conflict
Measured: The day of signing the clinical trial consent form
The decision preparation scale
Measures patients ability to prepare for decision-making
Measured: The day of signing the clinical trial consent form
Secondary outcomes (2)
The stages of decision making measure
Measures the stage patients are in during the decision-making process
Measured: 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.)
Measured: The day of signing the clinical trial consent form
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start19 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre- and post-intervention measures in two consecutive groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne W Kristensen, MSc, Study chair, Aarhus University HospitalCai W Grau, Professor, Study director, Aarhus University HospitalJeppe Friborg, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291610
- Sponsor's protocol ID
- Aarhus University Hospital
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing a Decision-support Intervention for Clinical Trials
- ClinicalTrials.gov ID
- NCT06291610
- Acronym / sponsor ID
- Aarhus University Hospital
- Conditions
- Head and Neck Neoplasms
- Keywords
- Clinical trial decision making, Patient involvement, Decision coaching, Feasibility study, Complex intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- The stages of decision making measure (self translated forward/backward)
- Decisional conflict scale
- The decision preparation scale (post intervention measure)
- Items on health literacy related to the specific context (understanding the trial, the treatment modalities, practical issues, etc.)
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre- and post-intervention measures in two consecutive groups.
| Arm | Type | Receives |
|---|---|---|
| Decision intervention group | Other | Behavioral: Clinical trial decision support interventionThe decision intervention will be tested in one arm (group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Dyslexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical trial decision support intervention1. 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. | Behavioural | Decision intervention group |
Primary outcome
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
2 secondary outcomes
The stages of decision making measure
Time frame: The day of signing the clinical trial consent form
Items on health literacy
Time frame: The day of signing the clinical trial consent form
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Neoplasms
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cai Grau, Professor contact
Anne W Kristensen, MSc study chair
Aarhus University Hospital
Cai W Grau, Professor study director
Aarhus University Hospital
Jeppe Friborg, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical trial decision support intervention in people with Head and Neck Neoplasms, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Kristensen, MSc (+4530315605, annkrs@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict scale (time frame: The day of signing the clinical trial consent form). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.