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

NCT07046884 | Recruiting

• 1 other identifier: N23.071
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Oncology

Keywords

Oncology; Integrated Care; Personalized treatment; Shared decision-making

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients with Discordance Between Standard Treatment Recommendation and Actual Treatment Decision

  This outcome measures the proportion of patients for whom the actual treatment decision deviates from the standard treatment recommendation based solely on medical-technical information. The standard treatment recommendation is defined in advance by oncology teams using medical-technical criteria (e.g., tumor type, stage, comorbidities), and is either collected prospectively from multidisciplinary tumor boards or derived from guideline-based recommendations documented in the electronic health record (EHR). The actual treatment decision is the treatment option selected by the clinical team and/or patient during the decision-making process, regardless of whether this treatment is ultimately delivered. Discordance is defined as any difference between the standard treatment recommendation and the actual treatment decision. This outcome will be used to evaluate whether implementing the IODM intervention, designed to support more personalized care, is associated with a change in discordance

  During the duration of the trial including 12-month follow-up (2 years)

Secondary Outcomes (27)

• Cancer-Related Quality of Life Assessed Using the EORTC QLQ-C30 Questionnaire

  2 years

• Age of Participants at Time of Enrollment (Years)

  2 years

• Frailty Assessed Using the Clinical Frailty Scale (CFS)

  2 years

• Resilience Assessed Using the Brief Resilience Scale (BRS)

  2 years

• Optimism Assessed Using the Life Orientation Test-Revised (LOT-R)

  2 years

Other Outcomes (3)

• Feasibility of Implementing the IODM Intervention Assessed by Healthcare Professional Questionnaire

  2 years

• Appropriateness of the IODM Intervention as Assessed by Healthcare Professionals

  2 years

• Acceptability of the Integrated Oncology Decision-Making Model (IODM) Assessed by Healthcare Professionals

  2 years

Study Arms (2)

Current care pathway (Control condition)

NO INTERVENTION

In this arm the participants receive care as usual.

IODM integrated care pathway

ACTIVE COMPARATOR

In this arm the participants receive care within an oncological care path that has integrated the IODM within their daily practice

Behavioral: Integrated Oncological Decision-making Model

Interventions

Integrated Oncological Decision-making Model BEHAVIORAL

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.

IODM integrated care pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient, partner, or caregiver cannot give informed consent

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (4)

University Medical Center Groningen (UMCG)

Groningen, 9713GZ, Netherlands

RECRUITING

Leiden University Medical Center (LUMC)

Leiden, 2333ZB, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

RECRUITING

Zuyderland MC

Sittard, 6162 BG, Netherlands

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Neoplasms

Study Officials

• Lieke Welling, MD PhD (Dr)

  Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieke Welling, MD PhD (Dr)

CONTACT

+31647140968; L.welling@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know whether their onocolgical care pathway has already integrated the IODM (intervention) or is practising care as usual (control)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. L. Welling

Model Details: The study will use a stepped-wedge cluster randomized trial design. Eight oncological care paths (clusters) will transition from current practice (control) to a locally tailored IODM-based practice (intervention condition) in four steps (two clusters per step), where order is determined by randomization.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: July 2, 2025
• Study Start: March 25, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)