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REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data

NCT06435091 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-05-16

No results posted yet for this study

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 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.

Conditions

  • Cancer Related Fatigue

Sponsors & Collaborators

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Svein Skeie, PhD · Helse Stavanger HF

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06435091 on ClinicalTrials.gov