Clinical Epidemiology and Aging Research

MIRANDA study (German name: “Mit dabei: Reha nach Darmkrebs”)

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In Germany, there are more than 60,000 new cases of colorectal cancer and more than 25,000 deaths from colorectal cancer per year. Although the prognosis has particularly improved for the early stages of the disease, detriments in the quality of life often persist. The occurrence of cancer-related fatigue is a major cause of reduced quality of life. One-third of colorectal cancer survivors suffer from fatigue shortly after initial treatment, but sometimes even years after the end of cancer therapy. Despite the heavy burden on the individual colorectal cancer patient, cancer-related fatigue is not adequately addressed in research. So far, only non-pharmacologic approaches have been shown to be effective.The MIRANDA study is an observational study and serves to establish a study cohort of patients with non-metastatic ("non-scattering") colorectal cancer that is representative of the German rehabilitation setting. The included patient population will be monitored over a maximum period of 10 years. The main criteria for participation in the study are hospitalization in one of the cooperating rehabilitation clinics for at least three weeks, diagnosis of non-metastatic colorectal cancer, and surgical removal of the tumor within the past nine months. The aim of the cohort study is to gain insights into risk, prevention and prognosis factors of cancer related fatigue, quality of life, the ability to work and further health outcomes among CRC patients. The required information from study participants will be obtained by using questionnaires as well as blood, urine, and stool samples. Endpoints, such as cancer-related fatigue, symptoms of depression, quality of life, and functional well-being will be assessed using validated questionnaire instruments (FACIT-F-FS, EORTC-FA-12, GDS-15, EORTC-QLQ-C30, and FACIT-F-FWB) and newly developed questionnaire instruments (e.g. for infection frequency and return to work) every 3 months in the first year and then after 3, 5, 7 and 10 years. Fatalities with causes of death are determined by register matching. At the beginning of the study, blood, urine and stool samples are collected to measure biomarkers and perform genetic analyses. A further stool sample is collected in the fourth month of the study to allow a longitudinal analysis of the microbiome.

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