OncologyIPTONCT07046884
Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making
A study testing Integrated Oncological Decision-making Model in people with Oncology, run by Leiden University Medical Center at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Integrated Oncological Decision-making Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesNetherlands
- Study dates
- 25 Mar 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient, partner, or caregiver cannot give informed consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites, 4 recruiting
- Recruiting
University Medical Center Groningen (UMCG)
Groningen, 9713GZ
Barbara van Leeuwen, Prof. MD., b.l.van.leeuwen@umcg.nl
Hanneke van der Wal-Huisman, Dr.
- Recruiting
Leiden University Medical Center (LUMC)
Leiden, 2333ZB
Lieke Welling, MD PhD (Dr.), l.welling@lumc.nl
Lieke Welling, MD PhD (Dr)
- Recruiting
Maastricht University Medical Center
Maastricht, 6229 HX
Trudy van der Weijden, Prof., trudy.vanderweijden@maastrichtuniversity.nl
Jesse Jansen, Dr.
- Recruiting
Zuyderland MC
Sittard, 6162 BG
Asiong Jie, Dr., a.jie@zuyderland.nl
Asiong Jie, Dr
About this study
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.
Read the detailed 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.
- Conditions
- Oncology
- Being tested
- Integrated Oncological Decision-making Model
- Keywords
- Oncology, Integrated Care, Personalized treatment, Shared decision-making
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Oncological Decision-making ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Integrated Oncological Decision-making Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Quality of life is measured using the EORTC QLQ-C30 questionnaire, which evaluates multiple domains: physical, role, cognitive, emotional, and social functioning; symptom scales such as fatigue and pain; and global health status. Scores range from 0 to 100. Higher scores indicate better functioning or health on functional and global scales, and greater symptom severity on symptom scales.
Measured: 2 years
Age of Participants at Time of Enrollment (Years)
Age is recorded in years based on participant self-report or medical records at the time of enrollment in the study. Data will be reported as mean, median, and range.
Measured: 2 years
Frailty Assessed Using the Clinical Frailty Scale (CFS)
Frailty is measured using the Clinical Frailty Scale (CFS), a clinician-reported tool that assesses a patient's vulnerability to adverse health outcomes based on their physical and cognitive condition. The scale ranges from 1 to 9, where 1 indicates very fit and 9 indicates terminally ill. Higher scores reflect greater frailty.
Measured: 2 years
Resilience Assessed Using the Brief Resilience Scale (BRS)
Resilience is measured using the Brief Resilience Scale (BRS), a patient-reported questionnaire designed to assess the ability to recover from stress. The scale ranges from 1 to 5, with higher scores indicating greater resilience.
Measured: 2 years
Optimism Assessed Using the Life Orientation Test-Revised (LOT-R)
Optimism is measured using the Life Orientation Test-Revised (LOT-R), a patient-reported questionnaire that assesses an individual's general tendency toward optimism versus pessimism. Scores range from 0 to 24, with higher scores indicating greater optimism.
Measured: 2 years
Mean Score on Quality of Life Impact of Symptoms Assessed with EORTC QLQ-C30 and Additional Items (coping with side effects)
This outcome measures how well patients cope with side effects from cancer treatment, operationalized as the self-reported impact of symptoms on various quality of life (QoL) domains. Symptoms are identified using disease-specific EORTC questionnaires. The impact of these symptoms is measured using items from the EORTC QLQ-C30 Core Quality of Life questionnaire, supplemented with additional questions covering domains not fully captured by the QLQ-C30, including physical functioning, emotional well-being, independence, social relationships, meaning in life, and daily activities. Scores are aggregated by calculating mean scores per domain and overall, with higher scores indicating greater impact and therefore lower coping effectiveness.
Measured: 2 years
Shared Decision-Making Assessed Using the I-Share Questionnaire
Shared decision-making is measured using the 5-Likert scale, 17-item I-Share questionnaire, a patient-reported outcome measure that assesses the patient's experience of shared decision-making during medical consultations. Higher scores indicate a greater perceived level of shared decision-making.
Measured: 2 years
Decisional Conflict Assessed Using the Decisional Conflict Scale
Decisional conflict is measured using the Decisional Conflict Scale, a patient-reported questionnaire that evaluates uncertainty and perceived difficulty in making a health-related decision. Scores range from 0 to 100, with higher scores indicating greater decisional conflict. 16 item 5 response categories.
Measured: 2 years
Decision Regret Assessed Using the Decision Regret Scale
Decision regret is measured using the Decision Regret Scale, a patient-reported questionnaire that assesses the level of regret a patient feels after making a health-related decision. Scores range from 0 to 100, with higher scores indicating greater decision regret. 5 items, 5 answer categories
Measured: 2 years
Patient Role Preference Assessed Using the Modified Control Preference Scale
The Modified Control Preference Scale is a patient-reported measure that assesses the patient's perceived and preferred role in the treatment decision-making process. Responses are categorized into three groups reflecting whether the patient prefers a passive role (decision made by the clinician), a shared role (decision made together with the clinician), or an active role (decision made primarily by the patient). 1-Item, 5 categories.
Measured: 2 years
Type of Companion Present During Treatment Decision Consultation as Recorded in the Electronic Medical Record (EMR)
This outcome records the type of companion (e.g., partner, child, friend, or other caregiver) who was present during the treatment decision consultation. Information is extracted from the electronic medical record (EMR), where the presence and relationship of companions are noted by clinical staff when available. Data will be reported as counts per companion type.
Measured: 2 years
Shared Decision-Making Assessed Using Observational Coding with the 4SDM Framework
Shared decision-making is measured through researcher-coded audio recordings of clinical consultations, using the 4SDM observational framework. The coding assesses the extent to which shared decision-making principles were applied during the consultation, including steps such as team talk, option talk, preference talk, and decision talk.
Measured: 2 years
Patients' Perception of Patient-Centeredness Assessed Using a Patient-Reported Questionnaire
Patient-centeredness is measured using a patient-reported questionnaire that assesses the extent to which patients perceive their care as aligned with their individual values, needs, and preferences. Scores indicate the degree of patient-centeredness experienced, with higher scores reflecting a greater perception of personalized, respectful, and responsive care.
Measured: 2 years
Participant Sex as Recorded in the Electronic Medical Record (EMR)
Sex is recorded as part of routine clinical documentation and extracted from the electronic medical record (EMR). Categories include: male and female. Data will be reported as the number of participants in each category.
Measured: 2 years
Migration Background Based on Self-Reported Country of Birth and Parental Origin
Migration background is determined based on self-reported data on the participant's own country of birth and the countries of birth of both parents. Participants are categorized according to national guidelines into groups such as: no migration background, first-generation migrant (participant born abroad), or second-generation migrant (participant born in the reporting country with at least one parent born abroad). Data will be reported as counts per category.
Measured: 2 years
ighest Level of Education Completed as Self-Reported by Participant
Education level is measured based on self-reported data from participants indicating the highest level of education they have completed. Categories include, for example: primary education, secondary education, vocational training, and higher education (e.g., university or equivalent). Data will be reported as the number of participants in each education category.
Measured: 2 years
Living Situation as Self-Reported by Participant
Living situation is measured using self-reported data from participants, indicating with whom they live. Response categories include: living alone, living with a partner, living with family (e.g., children or parents), or living with others (e.g., housemates, caregivers). Data will be reported as the number of participants in each category.
Measured: 2 years
Health Literacy Assessed Using a Three-Item Dutch Version of the SBS-Q
Health literacy is measured using a three-item Dutch version of the Set of Brief Screening Questions (SBS-Q), a patient-reported questionnaire that assesses an individual's ability to understand and use health-related information. Each item is scored on a 5-point Likert scale. Responses are combined into an overall score, with higher scores indicating lower health literacy. Data will be reported as mean scores and/or categorized into levels of health literacy (e.g., adequate vs. inadequate).
Measured: 2 years
Activities of Daily Living using Katz ADL
Description: Functional independence in basic activities of daily living is assessed using the Katz ADL Index, a patient-reported measure. The Katz ADL evaluates the ability to perform tasks such as bathing, dressing, toileting, transferring, continence, and feeding.
Scoring: The Katz ADL provides scores ranging from 0 (completely dependent) to 6 (completely independent), with higher scores indicating greater independence.
Measured: 2 years
Type of Tumour Working Group Involved in the Case as Recorded in the Medical Record
This outcome captures which multidisciplinary tumour working group (e.g., breast, lung, gastrointestinal) was responsible for managing each case. The data are extracted from the medical record or tumour board documentation. Each participant is assigned to a tumour working group based on their primary diagnosis. Data will be reported as the number of participants per tumour group.
Measured: 2 years
Histological or Pathological Tumor Type as Recorded in the Medical Record
The tumor type is classified based on histological or pathological examination results documented in the medical record. Tumors are categorized according to established classification systems relevant to the cancer type (e.g., adenocarcinoma, squamous cell carcinoma). Data will be reported as counts per tumor type category.
Measured: 2 years
verall Tumor Stage Assessed Using the TNM Classification
The overall stage of the cancer is determined according to the TNM classification system, based on tumor size (T), lymph node involvement (N), and presence of metastases (M). Stages are categorized from I to IV, with higher stages indicating more advanced disease. Data will be reported as the number of participants in each stage category.
Measured: 2 years
TNM Score Based on Tumor Size, Lymph Node Involvement, and Metastasis
The TNM score summarizes cancer staging by evaluating three components: T (tumor size and extent), N (lymph node involvement), and M (presence of distant metastases). Each component is assessed according to standard clinical criteria. The combined TNM score is used to classify disease severity and guide treatment decisions. Data will be reported as individual T, N, and M categories and as overall stage groups.
Measured: 2 years
Name of Hospital Providing Patient Care as Recorded in the Electronic Medical Record (EMR)
The hospital where the patient receives care is recorded in the electronic medical record (EMR). This information provides context regarding the healthcare setting and available infrastructure. Data will be reported as counts of patients per hospital.
Measured: 2 years
Number and Type of Clinicians Involved in Patient Care as Extracted from the Electronic Medical Record
The number and types of clinicians involved in each patient's care are extracted from the electronic medical record (EMR). This includes consultations and interactions with various specialists such as oncologists, surgeons, radiologists, palliative care specialists, and others. Data will be reported as the total number of clinicians seen per patient and as a breakdown by clinician specialty.
Measured: 2 years
Primary Treatment Decision Consultation as Recorded in the Electronic Medical Record (EMR)
This outcome captures details of the specific clinical consultation during which the primary treatment decision was made, as documented in the EMR. Data include the date of the consultation and the context/type of decision discussed, such as surgery, chemotherapy, or palliative care. This identifies the critical discussion shaping the patient's care plan.
Measured: 2 years
Primary Clinician Responsible for Patient Care as Recorded in the Electronic Medical Record (EMR)
The primary clinician responsible for managing the patient's care is identified based on documentation in the EMR. This includes the clinician's name, medical specialty (e.g., oncologist, surgeon), and their role in coordinating treatment and decision-making for the patient.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start25 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, lwelling, Leiden University Medical Center
- Investigators
- Lieke Welling, MD PhD (Dr), Principal investigator, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046884
- Sponsor's protocol ID
- N23.071
- Acronym
- IPTO
- Status last verified
- Jun 2025
- First submitted
- 30 Sep 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared among researchers within the consortium
Publications
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 28.
PubMed 34556384Brehaut 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.
PubMed 12926578Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
PubMed 15343421Festen 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.
PubMed 31031193Festen 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.
PubMed 33342722Hamaker 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.
PubMed 29631898Hansson 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.
PubMed 25595358Stiggelbout 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.
PubMed 26215573Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PubMed 18696313Scheier MF, Carver CS. Optimism, coping, and health: assessment and implications of generalized outcome expectancies. Health Psychol. 1985;4(3):219-47. doi: 10.1037//0278-6133.4.3.219.
PubMed 4029106Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869Reynolds A. Patient-centered Care. Radiol Technol. 2009 Nov-Dec;81(2):133-47.
PubMed 19901351O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Maizes V, Rakel D, Niemiec C. Integrative medicine and patient-centered care. Explore (NY). 2009 Sep-Oct;5(5):277-89. doi: 10.1016/j.explore.2009.06.008.
PubMed 19733814
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Personalized Treatment in Oncology: Effects of Integrated Oncological Decision-making
- ClinicalTrials.gov ID
- NCT07046884
- Acronym / sponsor ID
- IPTO / N23.071
- Conditions
- Oncology
- Keywords
- Oncology, Integrated Care, Personalized treatment, Shared decision-making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Current care pathway (Control condition) | No intervention | –In this arm the participants receive care as usual. |
| IODM integrated care pathway | Active comparator | Behavioral: Integrated Oncological Decision-making ModelIn this arm the participants receive care within an oncological care path that has integrated the IODM within their daily practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patient, partner, or caregiver cannot give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Oncological Decision-making ModelIn 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. | Behavioural | IODM integrated care pathway |
Primary outcome
Proportion of Patients with Discordance Between Standard Treatment Recommendation and Actual Treatment Decision
Time frame: 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
27 secondary outcomes
Cancer-Related Quality of Life Assessed Using the EORTC QLQ-C30 Questionnaire
Time frame: 2 years
Age of Participants at Time of Enrollment (Years)
Time frame: 2 years
Frailty Assessed Using the Clinical Frailty Scale (CFS)
Time frame: 2 years
Resilience Assessed Using the Brief Resilience Scale (BRS)
Time frame: 2 years
Optimism Assessed Using the Life Orientation Test-Revised (LOT-R)
Time frame: 2 years
Mean Score on Quality of Life Impact of Symptoms Assessed with EORTC QLQ-C30 and Additional Items (coping with side effects)
Time frame: 2 years
Shared Decision-Making Assessed Using the I-Share Questionnaire
Time frame: 2 years
Decisional Conflict Assessed Using the Decisional Conflict Scale
Time frame: 2 years
Decision Regret Assessed Using the Decision Regret Scale
Time frame: 2 years
Patient Role Preference Assessed Using the Modified Control Preference Scale
Time frame: 2 years
Type of Companion Present During Treatment Decision Consultation as Recorded in the Electronic Medical Record (EMR)
Time frame: 2 years
Shared Decision-Making Assessed Using Observational Coding with the 4SDM Framework
Time frame: 2 years
Patients' Perception of Patient-Centeredness Assessed Using a Patient-Reported Questionnaire
Time frame: 2 years
Participant Sex as Recorded in the Electronic Medical Record (EMR)
Time frame: 2 years
Migration Background Based on Self-Reported Country of Birth and Parental Origin
Time frame: 2 years
ighest Level of Education Completed as Self-Reported by Participant
Time frame: 2 years
Living Situation as Self-Reported by Participant
Time frame: 2 years
Health Literacy Assessed Using a Three-Item Dutch Version of the SBS-Q
Time frame: 2 years
Activities of Daily Living using Katz ADL
Time frame: 2 years
Type of Tumour Working Group Involved in the Case as Recorded in the Medical Record
Time frame: 2 years
Histological or Pathological Tumor Type as Recorded in the Medical Record
Time frame: 2 years
verall Tumor Stage Assessed Using the TNM Classification
Time frame: 2 years
TNM Score Based on Tumor Size, Lymph Node Involvement, and Metastasis
Time frame: 2 years
Name of Hospital Providing Patient Care as Recorded in the Electronic Medical Record (EMR)
Time frame: 2 years
Number and Type of Clinicians Involved in Patient Care as Extracted from the Electronic Medical Record
Time frame: 2 years
Primary Treatment Decision Consultation as Recorded in the Electronic Medical Record (EMR)
Time frame: 2 years
Primary Clinician Responsible for Patient Care as Recorded in the Electronic Medical Record (EMR)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 34556384Bomhof-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 28.
- Background: PubMed 12926578Brehaut 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.
- Background: PubMed 15343421Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
- Background: PubMed 31031193Festen 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.
- Background: PubMed 33342722Festen 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.
- Background: PubMed 29631898Hamaker 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.
- Background: PubMed 25595358Hansson 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.
- Background: PubMed 26215573Stiggelbout 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.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 18696313Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Background: PubMed 4029106Scheier MF, Carver CS. Optimism, coping, and health: assessment and implications of generalized outcome expectancies. Health Psychol. 1985;4(3):219-47. doi: 10.1037//0278-6133.4.3.219.
- Background: PubMed 16129869Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Individual participant dataSharing planned: No. Data will only be shared among researchers within the consortium
Related trials for Oncology
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lieke Welling, MD PhD (Dr) principal investigator
Department of Surgery
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Oncological Decision-making Model in people with Oncology, run by Leiden University Medical Center at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lieke Welling, MD PhD (Dr) (+31647140968, L.welling@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with Discordance Between Standard Treatment Recommendation and Actual Treatment Decision (time frame: During the duration of the trial including 12-month follow-up (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07046884, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.