Monitoring of Chronic Conditions in Breast Cancer

REBECCA-1 is an observational study. Clinical research is undergoing a revolutionary change. The use of electronic patient records (EHR), digital registers, smartphones etc will create "real-world data" (RWD) that provides great opportunities for advancing clinical research, but so far this opportunity has been little exploited. The REBECCA -1 study will observe and monitor fatigue in breast cancer survivors. Investigators will use self reported questionnaires (PROM-data), blood tests and objective regulations like the REBECCCA -1 smart watch that will register amount of steps every day, leaving the house, visiting friends, cafes etc. There will be three observational arms; 1.high fatigue, 2. low fatigue and 3. a healthy control arm. After the patients have finished their treatment, they will receive the REBECCA smart watch, a REBECCA app on the smart phone and a REBECCA plus device on their computer, The next offend are also invited to report their evaluation through the same apps. The observational time will be 1 year and comparison between the subjective PROM data , the objective REBECCA watch and the biological samples will be obtained.

NCT Number	NCT05587777
Lead Sponsor	Helse Stavanger HF
Conditions	Breast Cancer, Chronic Fatigue Syndrome
Enrollment	150 participants
Start Date	2022-06-15
Primary Completion	2024-06-15 (estimated)
Study Completion	2028-06-15 (estimated)
Updated on ClinicalTrials.gov	2022-10-20