Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making
NCT ID: NCT07046884
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-03-25
2026-03-31
Brief Summary
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Detailed Description
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Objectives: The primary objective of the current study is to evaluate the effect of the IODM on personalized decision-making and patient outcomes. We hypothesize that with the use of the IODM, decisions will more often differ from treatment recommendation based on clinical guidelines only, and that use of the IODM intervention will lead to more personalized decisions. The secondary objective of this study is to perform an extensive process evaluation of the implementation and strategies of the IODM.
Study design: 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 population: Study participants will be a convenience sample of patients (n=400 total, n=50 per care path) from two oncological care paths per center, in four medical centers (LUMC, UMCG, MUMC+ and Zuyderland) in the Netherlands. The minimal age of participants is 18.
Intervention: 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.
Main study parameters/endpoints: Our primary outcome is the discordance between the treatment recommendation based on clinical guidelines and the final treatment decision. We will measure whether discordance is due to more personalized decision-making, using shared decision-making outcome measures, and assessment of IODM components.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Current care pathway (Control condition)
In this arm the participants receive care as usual.
No interventions assigned to this group
IODM integrated care pathway
In this arm the participants receive care within an oncological care path that has integrated the IODM within their daily practice
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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lwelling
Dr. L. Welling
Principal Investigators
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Lieke Welling, MD PhD (Dr)
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery
Locations
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University Medical Center Groningen (UMCG)
Groningen, , Netherlands
Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Zuyderland MC
Sittard, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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N23.071
Identifier Type: -
Identifier Source: org_study_id
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