Actively Recruiting
Monitoring of Chronic Conditions in Breast Cancer
Led by Helse Stavanger HF · Updated on 2022-10-20
150
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Monitoring of Chronic Conditions in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female breast cancer patients aged 19 to 80 years
- Histologically confirmed breast cancer stage 0 to III with no distant metastasis
- Patients starting neoadjuvant or adjuvant endocrine, chemotherapy, and/or radiation therapy within 3 months before study start
- Expected to live beyond the first 3 months after treatment begins
- Ability to understand the study protocol and participate in follow-up
- No psychological, family, social, or geographical barriers that would prevent study compliance and follow-up
You will not qualify if you...
- Male breast cancer patients
- Patients who do not agree to follow the study protocol
- Patients with a previous cancer diagnosis except for skin cancer treated only with surgery
- Patients previously treated with chemotherapy or radiation therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Helse Stavanger HF
Stavanger, Norway, 4068
Actively Recruiting
Research Team
T
Tone Hoel Lende, PhD
CONTACT
H
Håvard Søiland, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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