Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Maastricht University
- Enrollment
- 126
- Primary Endpoint
- Decisional conflict (patients, evaluation phase)
Study Overview
Brief Summary
This is a trial-specific (NCT03705403) decision aid (tPDA) for stage IV NSCLC patients that might want to participate.
We want to investigate if a tPDA would be (significantly) helpful for these patients in making a decision.
ImmunoSABR has a complex study design, we expect that the patients get a better overview of the trial via the tPDA because you can bring multiple tools together. (text, video, questions, pictures, timelines, etc.)
Detailed Description
A lung cancer patient might want to take part in the ImmunoSABR phase 2 trial (NCT03705403). Before they can decide, it is important that the patients understand why the research is being done and what it would involve for them.
This tPDA will give information about this trial via text, small movies, quiz and preferences. In the end, the patient will receive an overview of their choices.
Detailed Description ImmunoSABR:
IMMUNOSABR will include 126 patients. In this single-stage controlled randomised open-label phase II trial, we aim to demonstrate an absolute increase in progression-free survival (primary endpoint). PFS will be determined as the time between randomisation and disease progression, according to RECIST 1.1, death due to any cause or last patient contact alive and progression-free. Patients will be randomized between control (no immunocytokine) and experimental arms (with immunocytokine L19-IL2) in a 1:1 ratio. The accrual period will be 29 months (or 2.41 years), and the minimum follow-up will be 18 months (or 1.5 years), making the total study duration 47 months. Comparison between control and experimental arms will be made using the Log-Rank statistic. This test for superiority will be one-sided with the desired type I error of 0.10 and power of 0.90.
Patients enrolled in the trial will be randomised into the control arm (C-arm) or experimental arm (E-arm).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Decisional conflict (patients, evaluation phase)
Time Frame: 6months after randomization
Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and ImmunoSABR clinical trial. Answers will be clear for the patient; agree,neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA
Control Preference Scale (patients; evaluation phase)
Time Frame: 6months after randomization
Patient's preference to participate in medical decisions will be assessed using the 3-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and ImmunoSABR clinical trial . Questions and answers will be clear for the patient; agree, neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA
Patient's decisional needs to make a decision about participating a clinical trial
Time Frame: 1 year
Patients' decisional needs (development phase):semi-structured interviews with patients about the decision about their treatment, and what information the patients need to make.
Perception shared decision-making
Time Frame: 6months after randomization
Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and ImmunoSABR clinical trial. 9 questions with clear answers; totally disagree, strongly disagree, disagree, agree, strongly agree, totally agree.
Usability of the decision aid
Time Frame: 1 year
Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire measure to what extent the decision aid is easy to use. Answers will be clear for the patient; agree, neutral, disagree.
Secondary Outcomes
- Patients' intention to use and recommend tPDA to others(6months after randomization)
- Patients' satisfaction with decision aid(6months after randomization)