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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Proportion of Patients with Discordance Between Standard Treatment Recommendation and Actual Treatment Decision [Срок оценки: During the duration of the trial including 12-month follow-up (2 years)]

Вторичные конечные точки (12)

• Cancer-Related Quality of Life Assessed Using the EORTC QLQ-C30 Questionnaire [Срок оценки: 2 years]
• Age of Participants at Time of Enrollment (Years) [Срок оценки: 2 years]
• Frailty Assessed Using the Clinical Frailty Scale (CFS) [Срок оценки: 2 years]
• Resilience Assessed Using the Brief Resilience Scale (BRS) [Срок оценки: 2 years]
• Optimism Assessed Using the Life Orientation Test-Revised (LOT-R) [Срок оценки: 2 years]
• Mean Score on Quality of Life Impact of Symptoms Assessed with EORTC QLQ-C30 and Additional Items (coping with side effects) [Срок оценки: 2 years]
• Shared Decision-Making Assessed Using the I-Share Questionnaire [Срок оценки: 2 years]
• Decisional Conflict Assessed Using the Decisional Conflict Scale [Срок оценки: 2 years]
• Decision Regret Assessed Using the Decision Regret Scale [Срок оценки: 2 years]
• Patient Role Preference Assessed Using the Modified Control Preference Scale [Срок оценки: 2 years]
• Type of Companion Present During Treatment Decision Consultation as Recorded in the Electronic Medical Record (EMR) [Срок оценки: 2 years]
• Shared Decision-Making Assessed Using Observational Coding with the 4SDM Framework [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Patient, partner, or caregiver cannot give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Нидерланды · 4 центра

• University Medical Center Groningen (UMCG) — Groningen
• Leiden University Medical Center (LUMC) — Leiden
• Maastricht University Medical Center — Maastricht
• Zuyderland MC — Sittard

Публикации

• Bomhof-Roordink H, Stiggelbout AM, Gartner FR, Portielje JEA, de Kroon CD, Peeters KCMJ, Neelis KJ, Dekker JWT, van der Weijden T, Pieterse AH; iSHARE Study group. Patient and physician shared decision-making behaviors in oncology: Evidence on adequate measurement properties of the iSHARE questionnaires. Patient Educ Couns. 2022 May;105(5):1089-1100. doi: 10.1016/j.pec.2021.08.034. Epub 2021 Aug 2 PMID 34556384
• Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005. PMID 12926578
• Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94. PMID 15343421
• Festen S, Kok M, Hopstaken JS, van der Wal-Huisman H, van der Leest A, Reyners AKL, de Bock GH, de Graeff P, van Leeuwen BL. How to incorporate geriatric assessment in clinical decision-making for older patients with cancer. An implementation study. J Geriatr Oncol. 2019 Nov;10(6):951-959. doi: 10.1016/j.jgo.2019.04.006. Epub 2019 Apr 26. PMID 31031193
• Festen S, van der Wal-Huisman H, van der Leest AHD, Reyners AKL, de Bock GH, de Graeff P, van Leeuwen BL. The effect of treatment modifications by an onco-geriatric MDT on one-year mortality, days spent at home and postoperative complications. J Geriatr Oncol. 2021 Jun;12(5):779-785. doi: 10.1016/j.jgo.2020.12.003. Epub 2020 Dec 17. PMID 33342722
• Hamaker ME, Te Molder M, Thielen N, van Munster BC, Schiphorst AH, van Huis LH. The effect of a geriatric evaluation on treatment decisions and outcome for older cancer patients - A systematic review. J Geriatr Oncol. 2018 Sep;9(5):430-440. doi: 10.1016/j.jgo.2018.03.014. Epub 2018 Apr 7. PMID 29631898
• Hansson E, Ekman I, Swedberg K, Wolf A, Dudas K, Ehlers L, Olsson LE. Person-centred care for patients with chronic heart failure - a cost-utility analysis. Eur J Cardiovasc Nurs. 2016 Jun;15(4):276-84. doi: 10.1177/1474515114567035. Epub 2015 Jan 16. PMID 25595358
• Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9. doi: 10.1016/j.pec.2015.06.022. Epub 2015 Jul 15. PMID 26215573

Идентификаторы

NCT: NCT07046884 · N23.071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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