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| ID | Type | Description | Link |
|---|---|---|---|
| REBECCA-PROST | Other Identifier | European Union's Horizon 2020 | |
| 965231 | Other Grant/Funding Number | European Union's Horizon 2020 |
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The overall aim of the REBECCA project is to exploit the potential of "real-world data" to support clinical research and improve existing clinical workflow. The primary aim of the REBECCA-3 study is to use multi-source "real-world data" to monitor the quality of life (QoL) of prostate cancer patients who are affected by cancer-related fatigue during and after treatment. This is to investigate whether the REBECCA monitoring is accepted by male patients and can be used within various forms of cancer.
Study design: 40 prostate cancer patients that undergo radiology and/or chemotherapy treatment will be included at the time of diagnosis. After end of primary treatment, the patients will receive a smartwatch, and have to download a REBECCA patient app on their mobile and a PC plug-in on their PC so that we can monitor their QoL for 4 months. In addition to collecting digital QoL parameters through the REBECCA-system, patient-reported QoL measures will also be collected through standardized PROMs and self-evaluation forms. Further, biological samples (blood, urine, and faeces) are collected at three time points of the study (i.e., at the time of: diagnosis, completed treatment, and 4 months post treatment), to investigate immunologic biomarkers, DNA methylation patterns and microbiota for assessment of new biological and prognostic information related to the development of cancer-related fatigue in prostate cancer patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the average REBECCA system usage rate throughout the monitoring period. | Daily and weekly frequency of participant interactions with the REBECCA system. | From the end of treatment to the 4-month post-treatment follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QoL) measured by the EORTC-QLQ-C30. | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30 scores patients QoL on a scale of 0-100, where higher values indicate higher QoL. | At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Prostate cancer patients at Stavanger University Hospital, Norway
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| Name | Affiliation | Role |
|---|---|---|
| Svein Skeie, PhD | Helse Stavanger HF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavanger University Hospital | Stavanger | 4067 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41655181 | Derived | Stensland 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. |
| Label | URL |
|---|---|
| REBECCA Project Site | View source |
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| Quality of life (QoL) measured by the SF36-questionnaire. | The SF36 scores the patients physical and mental health on a scale of 0-100, where higher values indicate better health. | At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up |
| Quality of life (QoL) measured by the EPIC-26-questionnaire. | The Expanded Prostate Cancer Index Composite short form 26 (EPIC-26) scores the patients QoL on a scale of 0-100, where higher values indicate better health. | At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up |
| Fatigue in primary prostate cancer patients measured by the fVAS questionnaire. | The fatigue Visual Analog Scale (fVAS) scores fatigue on a scale of 0-100, where lower values indicate less fatigue, thus a reduction in fVAS score between timepoints indicates a reduction of fatigue. | At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up |
| Fatigue in primary prostate cancer patients measured by the FSS questionnaire. | The Fatigue Severity Scale (FSS) scores fatigue on a scale of 1-7, where lower values indicate less fatigue, thus a reduction in FSS score between timepoints indicates a reduction of fatigue. | At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up |
| Fatigue in primary prostate cancer patients measured by the FQ questionnaire. | The Fatigue Questionnaire (FQ) scores fatigue on a scale of 0-33, where lower values indicate less fatigue, thus a reduction in FQ score between timepoints indicates a reduction of fatigue. | At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up |
| REBECCA system index score | The REBECCA system index score is given as values between 0 and 100, where higher values indicate higher QoL. | At the 4-month post-treatment follow-up. |
| Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE) | Weekly measurements over a 4-month period. | From the end of treatment to the 4-month post-treatment follow-up. |
| Fatigue biomarkers in plasma of primary prostate cancer patients. | Measure levels of fatigue biomarkers: HSP90, IL1β, IL6, IL10, IL1βRa, and DNA methylation. | At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up |
| Gut microbiota composition in primary prostate cancer patients. | Long-read 16S rRNA sequencing of faecal samples to characterize the gut microbiota composition. | At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up |
| Correlation between the REBECCA system index score and QoL questionnaire scores. | REBECCA score (scale 0-100) correlation to the EORTC-QLQ-C30 (scale 0-100), SF36 (scale 0-100), and EPIC-26 (scale 0-100). | At the 4-month post-treatment follow-up. |
| Correlation between the REBECCA system index score and fatigue questionnaire scores. | REBECCA score (scale 0-100) correlation to the fVAS (scale 0-100), FSS (scale 0-7) and FQ (scale 0-33). | At the 4-month post-treatment follow-up. |
| Correlation between the REBECCA system index score and fatigue biomarker levels in plasma | REBECCA score (scale 0-100) correlation to fatigue biomarker levels of HSP90, IL1β, IL6, IL10, IL1βRa and DNA methylation in plasma. | At the 4-month post-treatment follow-up. |
| Correlation between the REBECCA system index score and fatigue biomarker levels in feces. | REBECCA score (scale 0-100) correlation to fatigue biomarker levels of pro-inflammatory and anti-inflammatory microbes in feces. | At the 4-month post-treatment follow-up. |
| Subjective assessments of system usability measured by the System Usability Scale questionnaire. | The System Usability Scale measures user satisfaction on a scale from 0-100, where a score >75 indicate system use satisfaction. | At the 4-month post-treatment follow-up. |