Monitoring of Chronic Conditions in Breast Cancer
Recruiting · NCT05587777 · Observational (researchers observe without assigning treatment) · Lead sponsor: Helse Stavanger HF
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Breast cancer patients with histologically detectable M0 breast cancer (stage 0-III) who require neoadjuvant or adjuvant endocrine, chemo and / or radiation therapy at least and no more than 3 months before initiation of study.
- Female breast cancer patients between 19 and 80 years of age.
- Patients who have increased their life expectancy beyond the first 3 months after starting treatment.
- Patients who have the ability to understand the protocol and can participate in the follow-up plan.
- Patients who have an absence of psychological, familial, sociological or geographical condition that potentially impedes compliance with the study protocol and follow-up plan.
Exclusion criteria
- Male breast cancer patients.
- Patients who do not agree to the study protocol.
- Patients with a previous cancer diagnosis (excluding skin cancer treated only by surgery).
- Patients who have previously been treated with some form of chemotherapy / radiation therapy.
Where it is running
1 location listed.
- Helse Stavanger HF - Stavanger, Norway