Monitoring fatigue in breast cancer survivors
Official title: REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
Run by Helse Stavanger HF · NCT05587777 · Data updated 2026-11-12
This study is testing how fatigue affects breast cancer survivors by using smart watches and apps to track their daily activities and energy levels after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years to 80 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Helse Stavanger HF Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Stavanger) |
| Status | Recruiting |
| Started | June 15, 2022 |
| Main results expected | June 15, 2024 |
| Study ends | June 15, 2028 |
| Registry record updated | October 20, 2022 |
| Trial ID | NCT05587777 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female breast cancer patients aged 19 to 80 who are undergoing or have recently completed treatment for stage 0-III breast cancer.
✕Probably not a fit
Patients with a previous cancer diagnosis (excluding skin cancer treated only by surgery) or those who do not agree to the study protocol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The REBECCA-1 study is an observational research project aimed at monitoring fatigue levels in breast cancer survivors using real-world data collected through electronic patient records, digital devices, and self-reported questionnaires. Participants will be categorized into three groups based on their fatigue levels: high fatigue, low fatigue, and a healthy control group. After completing their cancer treatment, patients will receive a smart watch and mobile app to track their daily activities and fatigue levels over time. This innovative approach aims to provide insights into the long-term effects of cancer treatment on fatigue and overall quality of life.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for fatigue in breast cancer survivors, improving their quality of life.
How similar studies have gone: This approach of using real-world data to monitor chronic conditions in cancer survivors is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Helse Stavanger HF
Stavanger, Norway Recruiting
Study contacts
- Study coordinator: Tone Hoel Lende, PhD
- Email: leth@SUS.no
- Phone: 47861295
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.