NCT05587777Recruiting
Monitoring of Chronic Conditions in Breast Cancer
REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
Source: ClinicalTrials.gov · Last updated 20 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 26 Sept 2022
- Start date
- 15 Jun 2022
- Primary completion date
- 15 Jun 2024
- Lead sponsor
- Helse Stavanger HF
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05587777
What you commit to
- Study type: Observational
- Planned participants: 150
- From 15 Jun 2022 to the primary completion date, 15 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously been treated with some form of chemotherapy / radiation therapy.
Other illness
- Male breast cancer patients.
- Patients with a previous cancer diagnosis (excluding skin cancer treated only by surgery).
Other
- Patients who do not agree to the study protocol.
Who the study is looking for
- 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.
Age in the registry: 19 years to 80 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helse Stavanger HF Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.