Monitoring fatigue in breast cancer survivors
REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
Helse Stavanger HF · NCT05587777
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | Female |
| Sponsor | Helse Stavanger HF (other gov) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Stavanger) |
| Trial ID | NCT05587777 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Stavanger
- Helse Stavanger HF — Stavanger, Norway (RECRUITING)
Study contacts
- Study coordinator: Tone Hoel Lende, PhD
- Email: leth@SUS.no
- Phone: 47861295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Chronic Fatigue Syndrome, fatigue, breast cancer