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

N/AActive Not RecruitingNCT06435091

Helse Stavanger HF40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cancer Related Fatigue

Eligibility

Sex: MALEMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evaluation of the average REBECCA system usage rate throughout the monitoring period.

Daily and weekly frequency of participant interactions with the REBECCA system.

Time frame: From the end of treatment to the 4-month post-treatment follow-up.

Secondary Outcomes

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.

Time frame: 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 SF36-questionnaire.

The SF36 scores the patients physical and mental health on a scale of 0-100, where higher values indicate better health.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At the 4-month post-treatment follow-up.

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes