Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07046884

Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making

Led by Leiden University Medical Center · Updated on 2025-07-02

400

Participants Needed

4

Research Sites

100 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

D

Dutch Cancer Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient's age 18 years or older
  • Patient is included in a participating oncological care path
  • Patient does not yet have a treatment plan
  • Patient, partner, or caregiver reads and speaks Dutch well enough to understand the research material and complete questionnaires
  • Patient must be able to participate in the decision-making process
Not Eligible

You will not qualify if you...

  • Patient, partner, or caregiver cannot give informed consent

AI-Screening

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Trial Site Locations

Total: 4 locations

1

University Medical Center Groningen (UMCG)

Groningen, Netherlands, 9713GZ

Actively Recruiting

2

Leiden University Medical Center (LUMC)

Leiden, Netherlands, 2333ZB

Actively Recruiting

3

Maastricht University Medical Center

Maastricht, Netherlands, 6229 HX

Actively Recruiting

4

Zuyderland MC

Sittard, Netherlands, 6162 BG

Actively Recruiting

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Research Team

L

Lieke Welling, MD PhD (Dr)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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