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Trial Title:
A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)
NCT ID:
NCT05548621
Condition:
Renal Cell Carcinoma
Renal Cell Carcinoma Metastatic
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
decision aid
renal cell carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Decision aid
Description:
Online interactive decision aid for RCC
Arm group label:
Post-test
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Patients clinically diagnosed with RCC
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Antonius Ziekenhuis
Address:
City:
Nieuwegein
Zip:
3435 CM
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Cato Bresser
Phone:
0631143301
Email:
c.bresser@antoniusziekenhuis.nl
Start date:
November 24, 2022
Completion date:
October 2024
Lead sponsor:
Agency:
St. Antonius Hospital
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
St. Antonius Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05548621
