A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Antonius Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients clinically diagnosed with RCC
Patients facing a decision which is addressed in the decision aids (T1 tumor or metastatic disease)
Written informed consent
Disqualifiers
Patients who are not able to fill in a questionnaire or undergo an interview individually
Trial population
Patients clinically diagnosed with RCC
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Decision aid
Other interventionOnline interactive decision aid for RCC
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Pre-test0 interventions
Group B: Post-test1 intervention
Trial outcomes
Primary outcomes
1
OPTION-5
Observed patient involvement in decision-making
Time frame
During consultationSecondary outcomes
1
Decisional conflict scale
Validated scale to measure personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty and effective decision making.
Time frame
Two weeks and nine weeks after consultation2
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.
Time frame
Two weeks after consultation3
Control preference scale
Validated measure of patient's preferred and actual roles in treatment decisions
Time frame
Two weeks after consultation4
SDM-Q-9
Validated questionnaire of perceived level of shared decision-making
Time frame
Health care professional: directly after consultatiion, patient: two weeks after consultationSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Antonius Hospital
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov