RecruitingNCT05587777

Monitoring of Chronic Conditions in Breast Cancer

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


Sponsor

Helse Stavanger HF

Enrollment

150 participants

Start Date

Jun 15, 2022

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is observing people with early-stage breast cancer (stages 0–III) who are receiving treatment, to learn more about how chronic health conditions develop or change during and after cancer therapy. Researchers will collect health data over time to better understand long-term wellbeing. **You may be eligible if...** - You are a woman between 19 and 80 years old - You have been diagnosed with breast cancer (no spread to distant organs) and started cancer treatment within the last 3 months - You are receiving at least hormone therapy, chemotherapy, or radiation - Your doctors expect you to live beyond the next 3 months - You are able to attend follow-up visits and understand the study plan **You may NOT be eligible if...** - Your personal, family, or geographic situation makes it hard to follow the study plan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Helse Stavanger HF

Stavanger, Norway

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NCT05587777


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