Digital accompaniment in cancer treatment
Together with the University Hospital Ulm, Data4Life has investigated the app-based involvement of patients in their colorectal cancer treatment in the ACCEPT study.
In order to reflect the patient perspective, interest in patient-reported outcomes (PROs) in clinical trials has increased significantly in recent years. Through PROs, patients themselves assess how the use of a medical intervention affects symptoms or health-related quality of life, among other things. They can be measured with scores or instruments called patient-reported outcome measures (PROMs). They are becoming increasingly relevant as patients, caregivers, physicians, regulatory agencies, and policymakers emphasize the need to capture the full personal and social context of a disease, its treatment, and its consequences.
Whether it is feasible to digitally record PROMs in the context of colorectal cancer surgery through an app-based monitoring of the patient pathway, and to what extent this is accepted by those being treated and those providing treatment, was investigated by Data4Life together with the University Hospital Ulm in the project ACCEPT (App-based evaluation of patient-reported outcomes in Colorectal Cancer Patients - a prospective cohort Trial).
For ACCEPT, Data4Life provided a digital solution to collect electronic questionnaires from study participants from February 2022 to March 2023.
The study cohort consisted of adult patients scheduled for elective colorectal cancer surgery at the Department of General and Visceral Surgery at Ulm University Hospital who provided written informed consent. They received information and instructions to create a user account in the Data4Life app. PROM questionnaires were used to follow the patients through the surgical process and treatment in the hospital as well as 80-100 days after discharge from the hospital.
In the app, study participants were able to record, store, and view their current health status, symptoms, and information about their behavior before surgery, during their hospital stay, and after discharge. This data was stored end-to-end in encrypted form in their user account and made available pseudonymously on the Data4Life analysis platform.
After successful data collection, a publication in a scientific journal is planned to make the results of the current analysis available to the public.