Image

A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)

A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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 details
    Renal Cell Carcinoma
    Renal Cell Carcinoma Metastatic

NCT05548621

St. Antonius Hospital

2 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.