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

Cancer Related Fatigue Clinical Trial

— REBECCA-3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435091
• Other study ID #: REBECCA3SUH
• Status: Recruiting
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Helse Stavanger HF
• Contact: Kjersti Tjensvoll, PhD
• Phone: 004747809206
• Email: tjensvollk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Related Fatigue
• Chronic Disease

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	Fatigue biomarkers in plasma of primary prostate cancer patients.	Measure levels of fatigue biomarkers: HSP90, IL1ß, IL6, IL10, IL1ßRa, 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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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, IL1ß, IL6, IL10, IL1ßRa and DNA methylation in plasma.	At the 4-month post-treatment follow-up.
Secondary	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.
Secondary	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.

External Links

•   REBECCA Project Site