Monitoring Fatigue in Breast Cancer Survivors Using Watches and Apps
Observes fatigue in breast cancer survivors using questionnaires, blood tests and a smartwatch.
Plain-language title generated from the registry record
Registry title: Monitoring of Chronic Conditions in Breast Cancer
Key facts
- Where
- Stavanger, NorwaySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 80 years old?
Source: NCT05587777, who can take part
Where in Norway
- Helse Stavanger HFStavanger, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Helse Stavanger HF
- Trial code
- NCT05587777
- Record updated
- 20 October 2022
- Original description
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.Read full original descriptionShow less
REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
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.
Inclusion: 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: Patients who have previously been treated with some form of chemotherapy / radiation therapy; Male breast cancer patients; Patients with a previous cancer diagnosis (excluding skin cancer treated only by surgery); Patients who do not agree to the study protocol.