Clinical trial · Interventional
Intervention Study Based on Real-world Data to Improve Quality of Life After Breast Cancer Treatment, the REBECCA-2 Study
REBECCA-2 Study: Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Related Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| REBECCA-assisted intervention 1 | Drug | — | UNRESOLVED |
| REBECCA-assisted intervention 2 | Behavioral | — | UNRESOLVED |
| Standard follow-up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard of care
- description
- Patients will receive standard follow-up according to national guidelines developed by the Norwegian Breast cancer group (NBCG).
- interventionNames
- Other: Standard follow-up
- type
- EXPERIMENTAL
- label
- Standard of care + REBECCA-assisted intervention
- description
- Patients will, in addition to receiving standard follow-up every 6 months, also receive REBECCA-assisted follow-up at frequencies when the REBECCA-system indicate this. The patients will receive a REBECCA smartwatch that they will wear for 12 months. They will also have to install a REBECCA patient app on their mobile and a REBECCA plug-in on their computer for objective RWD collection related to their QoL and lifestyle over the next 12 months. 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) who will create a personalized training programme, e.g. 2-4 sessions per week.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDStensland M, Bru KF, Austdal M, Dahl IH, Jonsdottir K, Lende TH, Heimvik C, Elve I, Omdal R, van der Giezen M, Kvivik I, Tangeland B, Davidsen L, Hashemi M, Cais A, van Dijk KJ, Seyoum Y, Blafjelldal V, Sola ST, Papadopoulos A, Kiriakidou N, Ioakeimidis I, Diou C, Sarafis I, Delopoulos A, Janssen EAM, Gilje B, Tjensvoll K. Monitoring cancer-related fatigue and quality of life in breast and prostate cancer patients after primary treatment: a study protocol for the REBECCA trials in Norway. Clin Exp Med. 2026 Feb 8;26(1):133. doi: 10.1007/s10238-026-02073-y. PMID 41655181