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

NCT07046884 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Integrated Oncological Decision-making Model

In the IODM-based practice, the following three information components should be incorporated when forming a personalized treatment plan: 1. State-of-the-art oncological treatment options with advantages and disadvantages; 2. General health status based on physical, psychosocial, and emotional functioning; 3. Goals and preferences of the patient, both in treatment and daily life. Together with the professionals, optimal tools and strategies to integrate these components within the care path will be discussed.

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Lieke Welling, MD PhD (Dr) · Department of Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046884 on ClinicalTrials.gov