NCT05587777 Monitoring of Chronic Conditions in Breast Cancer
| NCT ID | NCT05587777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helse Stavanger HF |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-06-15 |
| Primary Completion | 2024-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-06-15 with a primary completion date of 2024-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Svein Skeie, PhD
STUDY DIRECTOR
Helse Stavanger HF
Frequently Asked Questions
Who can join the NCT05587777 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 80 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05587777 currently recruiting?
Yes, NCT05587777 is actively recruiting participants. Contact the research team at leth@SUS.no for enrollment information.
Where is the NCT05587777 trial being conducted?
This trial is being conducted at Stavanger, Norway.
Who is sponsoring the NCT05587777 clinical trial?
NCT05587777 is sponsored by Helse Stavanger HF. The principal investigator is Svein Skeie, PhD at Helse Stavanger HF. The trial plans to enroll 150 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.