Introduction to the REBECCA Case Report Form

As of 2022, breast cancer is the most common form of cancer among women worldwide. Following their primary cancer treatment, women are facing significant challenges in their lives. These include physical symptoms, such as pain or fatigue, as well as emotional symptoms, including fear of cancer recurrence, leading to difficulties in their interpersonal relationships as well as their professional obligations.

Up to now, research on these conditions has been limited, not only due to lack of interest, but also due to lack of tools for measuring and studying such multivariate, complex phenomena. REBECCA aims to use multiple sources of information, focusing on real-world data, combined with appropriate data analysis methodologies to provide insight into the quality of life of breast cancer patients.

An important first step in this direction is the development of the REBECCA Case Report Form (CRF). The REBECCA CRF is the clinical data model of the REBECCA project, in the sense that it contains all the clinical variables, which will be measured during the studies in Sweden, Norway, and Spain, as well as all the questionnaires to be answered by the breast cancer patients. The data include information, which can easily be extracted from electronic health records, or easily provided by patients during the normal follow-up visits at the clinics.

In more detail, REBECCA’s data model includes general background information for breast cancer patients, as well as information regarding the tumour and treatment characteristics. These questions are answered by the clinicians at the moment the breast cancer patient inserts in the clinical study. After the initiation of the study, each patient visits the hospital at months 6, 12, 18 and 24. At these events, the clinicians will provide information relevant to the medication assigned to the patients. In addition to the clinical variables, the questionnaires included in the CRF will measure multidimensional aspects of breast cancer patients’ quality of life, such as: physical, social, emotional, and functional well-being.

The REBECCA model will first be used in three observational studies in Sweden, Norway, and Spain. In Sweden, it will be used to study the clinical and quality-of-life effects of paclitaxel chemotherapy-induced polyneuropathy. In Norway, it will be used to evaluate the effects of chronic cancer-related fatigue, for breast cancer patients receiving chemotherapy or radiotherapy treatments, including their work-life participation. In Spain, the CRF will be used to evaluate clinical and quality-of-life effects in patients who develop osteopenia and osteoporosis, as a consequence of ongoing adjuvant treatment with aromatase inhibitors.  The data model is an outcome of collaborative work between researchers at the Harokopio University of Athens, engineers at 8-Bells and the three clinical organisations participating in the project (Stavanger University Hospital, Region Stockholm Hospital and the Incliva Health Research Institute).