Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435091
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-03-14
Brief Title:
REBECCA-3 Study Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
Sponsor:
Helse Stavanger HF
Organization:
Helse Stavanger HF
Study Overview
Official Title:
REBECCA-3 Study Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REBECCA-3
Brief Summary:
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 andor 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 ie 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
Study design 40 prostate cancer patients that undergo radiology andor 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| REBECCA-PROST | OTHER | None | None |
| 965231 | OTHER_GRANT | None | None |