NCT07046884 Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making
| NCT ID | NCT07046884 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Oncology |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-03-25 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The research aims to evaluate an Integrated Oncological Decision-making Model (IODM) to tailor oncological treatment plans to individual patients. The primary objective is to assess the impact of the IODM on personalized decision-making and patient outcomes. The study will employ a stepped-wedge cluster randomized trial design involving eight oncological care paths across four medical centers in the Netherlands. The study population consists of 400 adult patients (50 per care path) who will undergo treatment based on either standard clinical guidelines (control) or the IODM (intervention). The intervention involves integrating three key components: oncological treatment options, patient's general health status, and patient's goals and preferences. The main study parameters include measuring the discordance between recommendations based on medical information and final treatment decisions, assessing whether discordance reflects more personalized decision-making, and evaluating the implementation process of the IODM.
Eligibility Criteria
Inclusion Criteria: * Patient's age = 18+ * Patient is included in participating oncological care path * Patient does not yet have a treatment plan * Patient, partner, or caregiver who reads and speaks Dutch sufficiently to understand the research material and to complete the questionnaires * Patient must be able to participate in the decision-making process Exclusion Criteria: • Patient, partner, or caregiver cannot give informed consent
Contact & Investigator
Lieke Welling, MD PhD (Dr)
PRINCIPAL INVESTIGATOR
Department of Surgery
Frequently Asked Questions
Who can join the NCT07046884 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oncology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07046884 currently recruiting?
Yes, NCT07046884 is actively recruiting participants. Contact the research team at L.welling@lumc.nl for enrollment information.
Where is the NCT07046884 trial being conducted?
This trial is being conducted at Groningen, Netherlands, Leiden, Netherlands, Maastricht, Netherlands, Sittard, Netherlands.
Who is sponsoring the NCT07046884 clinical trial?
NCT07046884 is sponsored by Leiden University Medical Center. The principal investigator is Lieke Welling, MD PhD (Dr) at Department of Surgery. The trial plans to enroll 400 participants.