Monitoring of Chronic Conditions in Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19-80
SponsorHelse Stavanger HF
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
All breast cancer patients who have undergone surgery at SUS, and who meet the inclusion criteria, will be informed about the REBECCA-1 sub-study and written electronic consent will be obtained from those who wish to participate. All potential participants will be women due to the nature of breast cancer.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsGroup A: Mild Cancer Related Fatigue
Group B: Cancer related Fatigue
Group C: Healthy control
Trial outcomes
Primary outcomes
1
Level of fatigue at diagnosis - baseline
Visual Analogue Scale (fVAS), which is a score from 0 to 100 mm marked on a 100 mm line on a paper.
Time frame
This will be done at diagnosis, before treatment.2
Change from baseline fVAS after treatment 6 months
fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
Time frame
6 months after diagnosis and treatment3
fVAS follow up 12 months
fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
Time frame
12 months after diagnosis and treatment4
fVAS follow up 18 months
fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
Time frame
18 months after diagnosis and treatmentSecondary outcomes
1
Activity and sleep disorder measured with a smart watch.
We may measure number of steps each day, papttern of movement and sleep quality
Time frame
This will be measured at month 62
Activity and sleep disorder measured with a smart watch.
We may measure number of steps each day, papttern of movement and sleep quality
Time frame
This will be measured at month 123
Activity and sleep disorder measured with a smart watch.
We may measure number of steps each day, papttern of movement and sleep quality
Time frame
This will be measured at month 18Sponsors and contacts
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Source ClinicalTrials.gov