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

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Oncology

Treatments: Behavioral: Integrated Oncological Decision-making Model

Study type: Interventional

Funder types: Other

Identifiers

NCT07046884

N23.071

Details and patient eligibility

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.

Full description

Rationale: Currently, oncological treatment plans and decision-making are predominantly based on medical information following strict guidelines. Based on the conviction that oncological treatment plans can and should be more tailored to the individual, an outline for the Integrated Oncological Decision-making Model (IODM) has been developed. The IODM aims to individualize treatment decisions through the integration of patient's health status and goals/preferences in formulating treatment decisions.

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Current care pathway (Control condition)

No Intervention group

Description:

In this arm the participants receive care as usual.

IODM integrated care pathway

Active Comparator group

Description:

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

Treatment:

Behavioral: Integrated Oncological Decision-making Model