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RECRUITING
NCT05587777

Monitoring of Chronic Conditions in Breast Cancer

Sponsor: Helse Stavanger HF

View on ClinicalTrials.gov

Summary

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.

Official title: REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data

Key Details

Gender

FEMALE

Age Range

19 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2022-06-15

Completion Date

2028-06-15

Last Updated

2022-10-20

Healthy Volunteers

Yes

Locations (1)

Helse Stavanger HF

Stavanger, Norway