Cancer types
  • Lung
Title of study
Assessing the Effect of Decision Support for Prophylactic Cranial Irradiation (PCI) for Small-Cell Lung Cancer Patients
Version Number
Approval Date 
1.0, 20 September 2017
Short Title
CZ-PCI
Study site
Principle Investigator
C. Roumen, PhD; A. Dekker, PhD
Investigator Maastro
A. Ankolekar, MSc; C. Roumen, PhD; A. Dekker, PhD
Sponsor
CZ
Trial registry
Objectives 

This study explores the effect of SDM for patients and their radiotherapy-oncologists who face the decision whether or not to include PCI as treatment in extensive stage small-cell lung cancer (SCLC-ED). The SDM process will be supported with a personalized survival prediction from a decision support sys-tem based on a prediction model for SCLC survival.

Primary Endpoint 

Proportion of patients who choose PCI immediately after the SDM talk compared to usual care based on retrospective data.

Secondary Endpoints 

• Patient’s satisfaction
• Patients’ perception of the decision-making process (Decisional Conflict, Control Preference, Shared Decision Making)
• Clinicians’ perception of the decision making process and model used (Shared Decision Making)
• Quality of life (treatment related toxicities, lung cancer specific and overall quality of life)
• Tumor and patient outcomes (local control, distant metastasis, progression free survival, over-all survival)
• Cost-effectiveness