Clinical trial · Interventional
Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Integrated Oncological Decision-making Model | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Current care pathway (Control condition)
- description
- In this arm the participants receive care as usual.
- type
- ACTIVE_COMPARATOR
- label
- IODM integrated care pathway
- description
- In this arm the participants receive care within an oncological care path that has integrated the IODM within their daily practice
- interventionNames
- Behavioral: Integrated Oncological Decision-making Model
Primary outcomes (1)
- measure
- Proportion of Patients with Discordance Between Standard Treatment Recommendation and Actual Treatment Decision
- timeFrame
- During the duration of the trial including 12-month follow-up (2 years)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (19)
- BACKGROUNDBomhof-Roordink H, Stiggelbout AM, Gartner FR, Portielje JEA, de Kroon CD, Peeters KCMJ, Neelis KJ, Dekker JWT, van der Weijden T, Pieterse AH; iSHARE Study group. Patient and physician shared decision-making behaviors in oncology: Evidence on adequate measurement properties of the iSHARE questionnaires. Patient Educ Couns. 2022 May;105(5):1089-1100. doi: 10.1016/j.pec.2021.08.034. Epub 2021 Aug 28. PMID 34556384
- BACKGROUNDBrehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005. PMID 12926578
- BACKGROUNDChew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94. PMID 15343421
- BACKGROUNDFesten S, Kok M, Hopstaken JS, van der Wal-Huisman H, van der Leest A, Reyners AKL, de Bock GH, de Graeff P, van Leeuwen BL. How to incorporate geriatric assessment in clinical decision-making for older patients with cancer. An implementation study. J Geriatr Oncol. 2019 Nov;10(6):951-959. doi: 10.1016/j.jgo.2019.04.006. Epub 2019 Apr 26. PMID 31031193
- BACKGROUNDFesten S, van der Wal-Huisman H, van der Leest AHD, Reyners AKL, de Bock GH, de Graeff P, van Leeuwen BL. The effect of treatment modifications by an onco-geriatric MDT on one-year mortality, days spent at home and postoperative complications. J Geriatr Oncol. 2021 Jun;12(5):779-785. doi: 10.1016/j.jgo.2020.12.003. Epub 2020 Dec 17. PMID 33342722
- BACKGROUNDHamaker ME, Te Molder M, Thielen N, van Munster BC, Schiphorst AH, van Huis LH. The effect of a geriatric evaluation on treatment decisions and outcome for older cancer patients - A systematic review. J Geriatr Oncol. 2018 Sep;9(5):430-440. doi: 10.1016/j.jgo.2018.03.014. Epub 2018 Apr 7. PMID 29631898