Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Proportion of Patients with Discordance Between Standard Treatment Recommendation and Actual Treatment Decision
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants will not know whether their onocolgical care pathway has already integrated the IODM (intervention) or is practising care as usual (control)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient, partner, or caregiver cannot give informed consent
研究组 & 干预措施
Current care pathway (Control condition)
In this arm the participants receive care as usual.
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
干预措施: Integrated Oncological Decision-making Model (Behavioral)
结局指标
主要结局
Proportion of Patients with Discordance Between Standard Treatment Recommendation and Actual Treatment Decision
时间窗: During the duration of the trial including 12-month follow-up (2 years)
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
次要结局
- Age of Participants at Time of Enrollment (Years)(2 years)
- Resilience Assessed Using the Brief Resilience Scale (BRS)(2 years)
- Optimism Assessed Using the Life Orientation Test-Revised (LOT-R)(2 years)
- ighest Level of Education Completed as Self-Reported by Participant(2 years)
- Living Situation as Self-Reported by Participant(2 years)
- Health Literacy Assessed Using a Three-Item Dutch Version of the SBS-Q(2 years)
- Activities of Daily Living using Katz ADL(2 years)
- Cancer-Related Quality of Life Assessed Using the EORTC QLQ-C30 Questionnaire(2 years)
- verall Tumor Stage Assessed Using the TNM Classification(2 years)
- TNM Score Based on Tumor Size, Lymph Node Involvement, and Metastasis(2 years)
- Frailty Assessed Using the Clinical Frailty Scale (CFS)(2 years)
- Patient Role Preference Assessed Using the Modified Control Preference Scale(2 years)
- Shared Decision-Making Assessed Using Observational Coding with the 4SDM Framework(2 years)
- Patients' Perception of Patient-Centeredness Assessed Using a Patient-Reported Questionnaire(2 years)
- Name of Hospital Providing Patient Care as Recorded in the Electronic Medical Record (EMR)(2 years)
- Primary Clinician Responsible for Patient Care as Recorded in the Electronic Medical Record (EMR)(2 years)
- Type of Tumour Working Group Involved in the Case as Recorded in the Medical Record(2 years)
- Histological or Pathological Tumor Type as Recorded in the Medical Record(2 years)
- Mean Score on Quality of Life Impact of Symptoms Assessed with EORTC QLQ-C30 and Additional Items (coping with side effects)(2 years)
- Shared Decision-Making Assessed Using the I-Share Questionnaire(2 years)
- Decisional Conflict Assessed Using the Decisional Conflict Scale(2 years)
- Decision Regret Assessed Using the Decision Regret Scale(2 years)
- Type of Companion Present During Treatment Decision Consultation as Recorded in the Electronic Medical Record (EMR)(2 years)
- Participant Sex as Recorded in the Electronic Medical Record (EMR)(2 years)
- Migration Background Based on Self-Reported Country of Birth and Parental Origin(2 years)
- Number and Type of Clinicians Involved in Patient Care as Extracted from the Electronic Medical Record(2 years)
- Primary Treatment Decision Consultation as Recorded in the Electronic Medical Record (EMR)(2 years)
研究者
lwelling
Dr. L. Welling
Leiden University Medical Center