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

Renal Cell Carcinoma Clinical Trial

— SDM-RCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548621
• Other study ID #: WW 22.121/NWMO22.06.013
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma
• Renal Cell Carcinoma Metastatic

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