Personalized cancer treatment using an integrated decision-making approach
Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making
This study tests an Integrated Oncological Decision-making Model to see if combining treatment options, a patient's overall health, and their personal goals helps adults with cancer get more personalized treatment decisions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 4 sites (Groningen and 3 other locations) |
| Trial ID | NCT07046884 on ClinicalTrials.gov |
What this trial studies
The trial uses a stepped-wedge cluster randomized design across eight oncological care paths in four Dutch medical centers, enrolling about 400 adult patients. Care paths will transition from usual guideline-based decision-making to the Integrated Oncological Decision-making Model (IODM) in randomized steps so all clusters eventually use the IODM. The intervention integrates three elements—available oncological treatment options, the patient’s general health status, and the patient's goals and preferences—into local care processes. Primary measures include the discordance between guideline-based recommendations and final treatment decisions and whether such discordance reflects more personalized decision-making, alongside a detailed process evaluation of implementation.
Who should consider this trial
Good fit: Adults (18+) who are enrolled in one of the participating oncological care paths, do not yet have a treatment plan, can read and speak Dutch, and are able to participate in the decision-making process.
Not a fit: Patients who already have a finalized treatment plan, cannot give informed consent, or cannot read/speak Dutch or participate in decision-making are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the IODM could produce treatment plans that better match patients' health and personal goals, improving the personalization of care and potentially patient satisfaction and outcomes.
How similar studies have performed: Shared decision-making and personalization approaches have shown benefits in other oncology settings, but applying the specific IODM across multiple care paths with a stepped-wedge implementation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Groningen and 3 other locations
- University Medical Center Groningen (UMCG) — Groningen, Netherlands (Recruiting)
- Leiden University Medical Center (LUMC) — Leiden, Netherlands (Recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)
- Zuyderland MC — Sittard, Netherlands (Recruiting)
Study contacts
- Principal investigator: Lieke Welling, MD PhD (Dr) — Department of Surgery
- Study coordinator: Lieke Welling, MD PhD (Dr)
- Email: L.welling@lumc.nl
- Phone: +31647140968
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.