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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05548621
Other study ID # WW 22.121/NWMO22.06.013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 24, 2022
Est. completion date October 2024

Study information

Verified date April 2024
Source St. Antonius Hospital
Contact Cato Bresser
Phone 0631143301
Email c.bresser@antoniusziekenhuis.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the effect of two decision aids for renal cell carcinoma (RCC) on the decision-making process and the quality of the decision.


Description:

Background: Treatment options for patients diagnosed with RCC depend on the stage of the disease, histopathology and patient's preferences and values regarding outcomes. For local (non-metastatic) disease, gold standard for treatment is surgical resection of the tumour. Besides this, ablative therapies or active surveillance could also be an option. For metastatic disease, targeted therapy and/or immunotherapy can be offered and new treatment options are being tested in clinical trials. The number of available treatment options for patients with RCC is increasing, but the availability of these options differs per hospital and the transparency about treatment options is limited, resulting in practice variation between hospitals. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients clinically diagnosed with RCC - Patients facing a decision which is addressed in the decision aids (T1 tumor or metastatic disease) - Written informed consent Exclusion Criteria: - Patients who are not able to fill in a questionnaire or undergo an interview individually

Study Design


Intervention

Other:
Decision aid
Online interactive decision aid for RCC

Locations

Country Name City State
Netherlands St. Antonius Ziekenhuis Nieuwegein Utrecht

Sponsors (2)

Lead Sponsor Collaborator
St. Antonius Hospital Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary OPTION-5 Observed patient involvement in decision-making During consultation
Secondary Decisional conflict scale Validated scale to measure personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty and effective decision making. Two weeks and nine weeks after consultation
Secondary Preparation for decision-making Validated scale that assesses the patient's perception of how useful a decision aid is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision. Two weeks after consultation
Secondary Control preference scale Validated measure of patient's preferred and actual roles in treatment decisions Two weeks after consultation
Secondary SDM-Q-9 Validated questionnaire of perceived level of shared decision-making Health care professional: directly after consultatiion, patient: two weeks after consultation
Secondary Knowledge check Objective assessment of patient's understanding of information relevant for the decision at stake using ten questions which can be answered as true/false/I don't know. Two weeks after consultation
Secondary Implementation of the decision aids Qualitative information about experiences with implementation and use of the decision aids will be obtained through semi-structured interviews with patients and healthcare professionals. Nine weeks after consultation
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