A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)
NCT ID: NCT05548621
Last Updated: 2025-05-15
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
180 participants
OBSERVATIONAL
2022-11-24
2025-12-31
Brief Summary
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Detailed Description
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Decision aids help patients to make decisions regarding treatment, particularly when there is not one medically superior treatment option. In this tools treatment options are explained, including outcome information such as possible side effects and benefits of therapy. Decision aids have proven to lead to increased patient knowledge, less anxiety in patients, improved health outcomes such as physical en mental health, reductions in unwarranted variation in care and costs, greater alignment of care with patients' values.
For patients with RCC, two decision aids are in development right now: one decision aid focussed on local disease and one decision aid focussed on metastatic disease. Using these decision aids, patients are encouraged to make a well-informed decision together with the healthcare professional.
Objective: To assess how the decision aids for RCC influence the quality of the decision-making processes for RCC, defined as the extent to which elements of shared decision-making (SDM) are observed.
Design, setting and participants: This study includes patients clinically diagnosed with RCC, facing a decision which is addressed in the decision aids. Study design will be a prospective multicenter pre-test post-test study.
Outcome measurements and statistical analysis: The primary endpoint of this study is the mean change in OPTION-5 score between pre-test and post-test groups. Secondary outcome measures include perceived quality of the decision-making process, quality of the decision and implementation of the decision aids.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pre-test
Patients with RCC receiving usual care (without use of the decision aids)
No interventions assigned to this group
Post-test
Patients with RCC using the decision aids
Decision aid
Online interactive decision aid for RCC
Interventions
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Decision aid
Online interactive decision aid for RCC
Eligibility Criteria
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Inclusion Criteria
* Patients facing a decision which is addressed in the decision aids (T1 tumor or metastatic disease)
* Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
St. Antonius Hospital
OTHER
Responsible Party
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Cato Bresser
Coordinating Investigator
Locations
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St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WW 22.121/NWMO22.06.013
Identifier Type: -
Identifier Source: org_study_id
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