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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Cell Carcinoma; Renal Cell Carcinoma Metastatic
• Intervention / Treatment: Other: Decision aid

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.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Cato Bresser; Phone Number: 0631143301; Email: c.bresser@antoniusziekenhuis.nl

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • Recruiting
      • St. Antonius Ziekenhuis
      • Contact: Cato Bresser; Phone Number: 0631143301; Email: c.bresser@antoniusziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients clinically diagnosed with RCC

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-test; Patients with RCC receiving usual care (without use of the decision aids)
Post-test; Patients with RCC using the decision aids	Other: Decision aid; Online interactive decision aid for RCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OPTION-5	Observed patient involvement in decision-making	During consultation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Control preference scale	Validated measure of patient's preferred and actual roles in treatment decisions	Two weeks after consultation
SDM-Q-9	Validated questionnaire of perceived level of shared decision-making	Health care professional: directly after consultatiion, patient: two weeks after consultation
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
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

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: renal cell carcinoma; decision aid
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Kidney Neoplasms; Carcinoma; Carcinoma, Renal Cell
• Other Study ID Numbers: WW 22.121/NWMO22.06.013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No