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Monitoring of Chronic Conditions in Breast Cancer

RECRUITINGSponsored by Helse Stavanger HF
Actively Recruiting
SponsorHelse Stavanger HF
Started2022-06-15
Est. completion2024-06-15
Eligibility
Age19 Years – 80 Years
SexFEMALE
Healthy vol.Accepted

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.

Eligibility

Age: 19 Years – 80 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions3

Breast CancerCancerChronic Fatigue Syndrome

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