Monitoring of Chronic Conditions in Breast Cancer

Recruiting now

Conditions studied: Breast Cancer, Chronic Fatigue Syndrome

In brief

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.

Key facts

Study ID

NCT05587777

Run by

Helse Stavanger HF

People needed

150

Starts

2022-06-15

Expected to finish

2028-06-15

Last updated by the study team

2022-10-20

Who can join

Age: 19 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Helse Stavanger HF — Stavanger, Norway (enrolling)

Full record on ClinicalTrials.gov

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