Trial Title:
Intervention Study Based on Real-world Data to Improve Quality of Life After Breast Cancer Treatment, the REBECCA-2 Study
NCT ID:
NCT06120595
Condition:
Cancer Related Fatigue
Conditions: Official terms:
Fatigue
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
REBECCA-assisted intervention 1
Description:
The intervention will include changes in medication (e.g. change from Letrozol to
Tamoxifen, treatment for polyneuropathy, osteoporosis).
Arm group label:
Standard of care + REBECCA-assisted intervention
Intervention type:
Behavioral
Intervention name:
REBECCA-assisted intervention 2
Description:
The intervention will include dietary advice, to a psychologist/psychiatrist and/or
personal training with a physiotherapist at 'Pusterommet' (SUH).
Arm group label:
Standard of care + REBECCA-assisted intervention
Intervention type:
Other
Intervention name:
Standard follow-up
Description:
Standard follow-up
Arm group label:
Standard of care
Arm group label:
Standard of care + REBECCA-assisted intervention
Summary:
The overall objective of the REBECCA studies at Stavanger University Hospital (SUH) is to
improve the QoL of patients affected by cancer-related fatigue during and after end of
treatment, by collecting multi-source real world data (RWD) and intervening based on the
collected RWD.
In the intervention study, REBECCA-2, the investigators will use the collected real world
data to provide a personalised follow-up to the breast cancer patients in order to
improve their quality of life. The patients in this study are randomised into 2 groups
after end of primary treatment:
- The control group (n=55): Patients will receive standard follow-up according to
national guidelines plus 3 generic lifestyle consultation sessions via telephone.
- The experimental REBECCA group (n=55): Patients will, in addition to receiving
standard follow-up also receive REBECCA-assisted follow-up. Data will be collected
from a REBECCA smartwatch, plug-in and PROMs.
If the REBECCA system detects signs of deterioration in patients' QoL during the study
period, the intervention will include changes in medication given, dietary advice,
referral to a psychologist/psychiatrist and/or personal training with a physiotherapist
at 'Pusterommet' (SUH)
After 12 months of RWD collection participants will be offered the option to continue in
the study for another 6 months. For patients in the experimental Rebecca group this
includes the use of the REBECCA system for another 6 months. In the clinical REBECCA-2
study, patients' visits are planned every 6 months and include collection of both PROMs
and biological samples.
Detailed description:
1. Background:
Clinical research is undergoing revolutionary changes by use of electronic patient
records (EHR), digital registers and smartphones. The widespread use of portable
devices have led to possibilities to collect "real-world data" (RWD) that provides
great opportunities for advancing clinical research.
Fatigue or exhaustion is one of the most common and most annoying late side effects
after breast cancer treatment. Cancer Related Fatigue (CRF) may be elevated even
before starting treatment and generally increases in intensity during treatment .
CRF is multi-dimensional and can have physical, mental and emotional manifestations,
including general weakness, decreased concentration or attention, decreased
motivation or interest in participating in regular activities, as well as emotional
lability. Fatigue has also been shown to have a negative impact on work, social
relationships, mood and daily activities and causes a significant reduction in
overall quality of life during and after treatment for the patients affected. Thus,
studying of RWD in CRF will be an appropriate method and design. As far as known
this has not been done before.
The biological mechanisms associated with the development of CRF may involve
inflammatory processes contribute to fatigue during and especially after cancer
treatment.
2. Rationale behind the REBECCA project:
By using multi-source RWD in clinical studies, it will be possible to monitor the
quality of life of patients and have a unique opportunity to map the challenges
patients have in their daily lives in terms of work life participation, physical
activity, social activity / relationships and their concerns. At the same time, the
investigators will explore whether different immunological candidate biomarkers can
provide prognostic information related to the development of fatigue in this patient
group.
3. Objectives:
The purpose of the REBECCA-2 study at SUS is to use multi-source RWD to monitor the
quality of life of breast cancer patients who are affected by fatigue during and
after cancer treatment, and to provide a more comprehensive and personal follow-up
to those with goals about improving the quality of life.
4. Specific aims include:
- To evaluate whether the use of REBECCA aggregated patient information (ie
collection of continuous RWD and PROMs) will contribute to better follow-up of
breast cancer patients in the first 12 months after completion of primary
treatment, as well as result in an improved quality of life for patients
participating in this study arm compared to which receives standard follow-up.
To evaluate whether the observed improvement is long-term, at least that it
will persist until the time of the 18-month evaluation.
- To evaluate whether an improvement in quality of life is associated with
improvements demonstrated by REBECCA's behavioral indicators, which are
calculated from continuous "real-world" REBECCA measurements. This will show
whether RWD can ensure a more efficient and better follow-up of breast cancer
patients after primary treatment has ended.
- To evaluate whether immunological biomarkers such as HSP90, IL1b, IL6, IL10,
IL-17, IL1 β Ra, IL1-RII, HPX, CFB, APOA4 and Serpin-F1 as well as DNA
methylation patterns can provide prognostic information related to the
development of fatigue in breast cancer patients.
- To evaluate whether an improvement in quality of life is associated with lower
reporting of cancer-related fatigue, and reduced levels of fatigue-related
biomarkers in the biological samples.
- To evaluate whether an improvement in quality of life is associated with
improvements in REBECCA's PROM index, calculated from continuous "real-world"
REBECCA measurements.
5. Study design:
In the intervention study, REBECCA-2, the investigators will use the collected real
world data to provide a personalised follow-up to the breast cancer patients in
order to improve their quality of life. The patients in this study are randomised
into 2 groups after end of primary treatment:
- The control group (n=55): Patients will receive standard follow-up according to
national guidelines plus 3 generic lifestyle consultation sessions via
telephone.
- The experimental REBECCA group (n=55):
The patients participating in the experimental study arm will be allowed to borrow a
smartwatch, which they must wear for 12 months. In addition, they must install a
REBECCA patient app on their mobile phone and a plug-in on their PC/laptop so that
the investigators can obtain objective "real-world data (RWD)" related to the
participants' quality of life and lifestyle over the next 12 months.
If the REBECCA system detects signs of deterioration in patients' QoL during the
study period, the intervention will include changes in medication given, dietary
advice, referral to a psychologist/psychiatrist and/or personal training with a
physiotherapist at 'Pusterommet' (SUH)
After 12 months of RWD collection participants will be offered the option to
continue in the study for another 6 months. For patients in the experimental Rebecca
group this includes the use of the REBECCA system for another 6 months. In the
clinical REBECCA-2 study, patients' visits are planned every 6 months and include
collection of both PROMs and biological samples.
The attending physician at SUS will have access to a summary of the "real-world"
patient data through "the Clinical Dashboard", in order to be able to actively use
this information to improve the follow-up of the patient.
Participants in the experimental arm will also be able to give permission for
others, e.g. family members or close friends, to contribute with information about
their physical and emotional state of health to REBECCA. This data is then reported
in the REBECCA companion app.
6. REAL WORLD DATA COLLECTION
A. Smartwatch:
Acceleration, pulse, Activity sessions (type of exercise (running, walking, walking,
cycling Length of activity(minutes, training distance (km) and altitude meters
Intensity level(number of calories, intensity)
B. Smartphone and mobile apps
- GPS positions (movement pattern)
- Answer to questionnaires
- Photo initiated in the Rebecca app (related to meals/eating habits and
environment)
- Publicity available data from map services location and environmental.
C. REBECCA. PC plug in internet from *Social media such as Facebook, You Tube etc.
D. REBECCA companion app (optional) *answer questions about the patient's quality of
life , symptoms and environment.
7. Patient Reported Outcome Measures (PROMs)
Patient-reported data (PROMs) related to lifestyle, quality of life, working
conditions, sleep and medication use will also be collected in REBECCA. For this
purpose, the investigators will both use standardized PROM forms (ΕORTC-QLQ-BR2340,
SF-3641, ΕORTC-QLQ-C3042, HAD43, FSS44, FQ45 og VAS-fatigue 34, 46, 47) and
self-report form.
8. Collection and analyses of blod-, urine- and faeces samples
All patients included in the REBECCA-2 sub-study will be asked to give blood, urine
and faeces samples i.) at the time of diagnosis ii.) after the end of treatment
(month 6) and iii.) at 12 and 18 months follow-up. A tissue sample will also be
taken at the time of diagnosis. The blood samples will be used to investigate
whether immunological biomarkers such as HSP90, IL1b, IL6, IL10, IL-17, IL1βRa,
IL1-RII, HPX, CFB, APOA4 and Serpin-F1-can provide prognostic information related to
the development of fatigue in breast cancer patients.
DNA methylation will be examined by Full-genome methylation assays using Illumina's
Human Methylation 850K platform and 8 CpG sites from our partner Mylin Torres will
in addition be validated.
9. Data flow
The REBECCA system will function as a data collection system, and will be a "stand
alone" system that will have no communication with other systems in the hospital.
i.) A smartwatch: The smartwatch to be used in REBECCA for RWD collection will be a
commercial Garmin-type smartwatch.
ii.) REBECCAs patient app (pApp): GPS data, data from third-party health apps,
images and sensor data will first be uploaded to REBECCA's pApp. The data will be
stored in the app on a separate memory location on the phone, which is isolated and
therefore not available for the other phone apps. .
iii.) REBECCAs PC plug-in: patients will install this on their PC. The REBECCA's PC
plug-in utilizes the browser's local storage space to store information that is
critical to its functionality, while the data from the patient's online activity is
directly transferred and stored on the REBECCA server for subsequent processing.
iv.) REBECCAs companion app (cApp): Family members or close friends who will
contribute information to REBECCA will report this data in REBECCA's companion app,
which they will install on their mobile. .
v.) RedCap server at HelseVest IKT: Deidentified clinical data and PROM data will be
stored in the RedCap server at HelseVest IKT before being transferred pseudonymously
and encrypted to the remotely managed REBECCA server.
10. Data storage, privacy and data security
Data security and privacy are a high priority in REBECCA and will of course be in
line with both Norwegian and European laws. The law firm TimeLex, located in
Belgium, is responsible for creating an operational data security and ethical
framework that the study will follow. This means that all precautions will be taken
in REBECCA to respect the privacy of study participants in accordance with European
Parliament and Council Regulation (EU) 2016/679 of 27 April 2016 regarding the
protection of individuals with regard to the processing of personal data and the
free movement of such data , and repealing Directive 95/46 / EC (General Data
Protection Regulation) (GDPR))50. TimeLex, will identify and describe the ethical
guidelines that apply to the various REBECCA participating countries, and the list
of necessary measures will apply to the entire ethical operation of the REBECCA
project.
11. Expected impact of the REBECCA project
REBECCA aims to use "real-world data" combined with an advanced data management
platform and innovative methods for modeling causal data, to close the gap between
clinical research and clinical practice in the treatment of cancer patients. The
REBECCA project will initially focus on breast cancer, but will also demonstrate the
REBECCA system's transmission to other cancers such as prostate cancer. REBECCA's
technological and methodological advances will also be relevant for other clinical
research domains that want to investigate the causal relationship between several
clinical factors, through analysis of registry and biobank data and observational
data from patients' real life / everyday life.
12. Among REBECCAs milestones are:
A. Development of new approaches to measurement, and a better understanding, of
indicators related to the patient's health status and quality of life.
B. Development of methods for statistical and causal analysis of "real-world data".
C. Clinical studies in cancer-related fatigue / fatigue, cancer-induced peripheral
neuropathy and cancer-related osteoporosis.
D. Examination of patient monitoring in clinical trials, as a tool to improve the quality
of life of cancer patients.
E. Generation and reuse of data sets that will enable the investigation of new medical
issues as well as the design, implementation and delivery of an AI-enhanced data
collection and management system for comprehensive monitoring of breast cancer survivors'
health status and quality of life.
F. To offer new tools and data to clinicians that lead to improved follow-up of cancer
patients.
G. Improved patient experience and quality of life due to detailed monitoring and a more
personal follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants have had histologically proven M0 breast cancer (stage 0-II) breast
cancer that require neoadjuvant or adjuvant chemo- and/or radio-therapy at least and
no more than 3 months pre-study initiation.
- Age between 19 and 80 years
- Have increased life expectancy beyond the initial 3 months post-treatment.
- Have the ability to understand protocol, participate in testing and willingness to
sign a written informed consent.
- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule.
Exclusion Criteria:
- Male breast cancer patients
- Patients that are not willing to sign an informed consent form
- A previous cancer diagnosis (excluding skin cancers treated by surgery only)
- Patients previously treated by any form of chemo/radiotherapy.
Gender:
Female
Minimum age:
19 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Stavanger University Hospital
Address:
City:
Stavanger
Zip:
4067
Country:
Norway
Start date:
November 1, 2022
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Helse Stavanger HF
Agency class:
Other
Source:
Helse Stavanger HF
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120595
