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

Helse Stavanger HF

Status: Enrolling

Conditions: Cancer Related Fatigue

Study type: Observational

Funder types: Other

Identifiers

NCT06435091

REBECCA3SUH

965231 (Other Grant/Funding Number)

REBECCA-PROST (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate cancer patients with histologically detectable M0 prostate cancer requiring primary surgery or primary radiation therapy followed by hormone therapy at least and no more than 3 months of initiation prior to study start
• Male prostate cancer patients under 80 years of age.
• Patients who have an increased life expectancy beyond the first 3 months after starting treatment.
• Patients who have the ability to understand the protocol and can participate in the follow-up plan.
• Patients who have the absence of psychological, familial, sociological, or geographic condition potentially hindering compliance with the study protocol and follow-up schedule.
• Patients who have a smart phone.

Exclusion criteria

• Patients who do not consent to the study protocol.
• Patients with a previous cancer diagnosis (except skin cancer treated only by surgery).
• Patients who have previously been treated with any form of chemotherapy/radiotherapy.
• Foreign-language patients without sufficient Norwegian understanding
• Patients who do not have a smartphone