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

NCT05548621 | Recruiting

• 1 other identifier: WW 22.121/NWMO22.06.013
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma; Renal Cell Carcinoma Metastatic

Keywords

decision aid; renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• OPTION-5

  Observed patient involvement in decision-making

  During consultation

Secondary Outcomes (6)

• Decisional conflict scale

  Two weeks and nine weeks after consultation

• Preparation for decision-making

  Two weeks after consultation

• Control preference scale

  Two weeks after consultation

• SDM-Q-9

  Health care professional: directly after consultatiion, patient: two weeks after consultation

• Knowledge check

  Two weeks after consultation

Study Arms (2)

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

Interventions

Decision aid OTHER

Online interactive decision aid for RCC

Post-test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients clinically diagnosed with RCC

You may qualify if:

• Patients clinically diagnosed with RCC
• Patients facing a decision which is addressed in the decision aids (T1 tumor or metastatic disease)
• Written informed consent

You may not qualify if:

• Patients who are not able to fill in a questionnaire or undergo an interview individually

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Cato Bresser

CONTACT

0631143301; c.bresser@antoniusziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: November 24, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

NL (1)