Patient engagement in a Non-Interventional Study
PROMETCO is an example of a long-term patient involvement in a clinical research project to better understand routine clinical practice in mCRC.
PROMETCO is a real-world evidence prospective cohort study in the management of metastatic colorectal cancer (mCRC). The PROMETCO study aims to collect real-world data on 1000 patients from around 18 countries in Europe and Argentina; recruitment is currently ongoing. The study objective is to bring a clinical and patient perspective on overall survival, treatment patterns and associated effectiveness and safety, and to understand the continuum of care of patients with mCRC.
Involvement of Patients with Colorectal Cancer (CRC) from Digestive Cancers Europe
PROMETCO is an example of long-term patient involvement in a clinical research project. It aims to better understand routine clinical practice in mCRC.
Sharing the patient experience is essential in research projects so that the patient input complements the science and makes a difference in future treatment choices. Being involved in these types of projects allows, for example, to simplify the patient’s pathway in the study protocols (such as adapting the frequency of hospital visits or number of medical examinations) or to define the outcomes that are of interest to patients.
After a first patient engagement initiative with Digestive Cancer Europe (EuropaColon; DICE) to review the Informed Consent Form of the study, the collaboration has been expanded to continuously bring the patient perspective to the heart of the project.
Approximately 10 patients with CRC from DICE were involved in selecting relevant patient-reported outcomes (PROs) questionnaires in order to facilitate them being filled in by all study participants and to better understand participants’ voice. These questionnaires are used to record patients’ answers in relation to their quality of life, fatigue and treatment acceptance at the start of and all along their journey through the PROMETCO study. Five questionnaires were submitted to patients and three of them were selected to be used in the study. Among these three, one was adapted following patient feedback.
Throughout the study, consultations with patients are being organized to gather their views on certain topics and adapt the study accordingly. Recently, the patients’ views on the COVID-19 pandemic and the impact on patients with mCRC have been essential to adapt the study to the current context. Thanks to the shared experience of the DiCE patient group, an online platform has been set up. This allows all study participants to complete the questionnaires directly from their homes, even if they cannot come to the hospital in person.
If you would like to to take part in the PROMETCO study please see this website.