Cancer Related Fatigue
Conditions
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 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.
Interventions
None listed
Sponsors
Helse Stavanger HF
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the average REBECCA system usage rate throughout the monitoring period. | From the end of treatment to the 4-month post-treatment follow-up. | Daily and weekly frequency of participant interactions with the REBECCA system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QoL) measured by the SF36-questionnaire. | 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 | The SF36 scores the patients physical and mental health on a scale of 0-100, where higher values indicate better health. |
| Quality of life (QoL) measured by the EPIC-26-questionnaire. | 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 | 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. |
| Fatigue in primary prostate cancer patients measured by the fVAS questionnaire. | 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 | 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. |
| Fatigue in primary prostate cancer patients measured by the FSS questionnaire. | 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 | 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. |
| Fatigue in primary prostate cancer patients measured by the FQ questionnaire. | 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 | 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. |
| REBECCA system index score | At the 4-month post-treatment follow-up. | The REBECCA system index score is given as values between 0 and 100, where higher values indicate higher QoL. |
| Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE) | From the end of treatment to the 4-month post-treatment follow-up. | Weekly measurements over a 4-month period. |
| Quality of life (QoL) measured by the EORTC-QLQ-C30. | 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 | 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. |
| Gut microbiota composition in primary prostate cancer patients. | 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 | Long-read 16S rRNA sequencing of faecal samples to characterize the gut microbiota composition. |
| Correlation between the REBECCA system index score and QoL questionnaire scores. | At the 4-month post-treatment follow-up. | REBECCA score (scale 0-100) correlation to the EORTC-QLQ-C30 (scale 0-100), SF36 (scale 0-100), and EPIC-26 (scale 0-100). |
| Correlation between the REBECCA system index score and fatigue questionnaire scores. | At the 4-month post-treatment follow-up. | REBECCA score (scale 0-100) correlation to the fVAS (scale 0-100), FSS (scale 0-7) and FQ (scale 0-33). |
| Correlation between the REBECCA system index score and fatigue biomarker levels in plasma | At the 4-month post-treatment follow-up. | REBECCA score (scale 0-100) correlation to fatigue biomarker levels of HSP90, IL1β, IL6, IL10, IL1βRa and DNA methylation in plasma. |
| Correlation between the REBECCA system index score and fatigue biomarker levels in feces. | At the 4-month post-treatment follow-up. | REBECCA score (scale 0-100) correlation to fatigue biomarker levels of pro-inflammatory and anti-inflammatory microbes in feces. |
| Subjective assessments of system usability measured by the System Usability Scale questionnaire. | At the 4-month post-treatment follow-up. | The System Usability Scale measures user satisfaction on a scale from 0-100, where a score \>75 indicate system use satisfaction. |
| Fatigue biomarkers in plasma of primary prostate cancer patients. | 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 | Measure levels of fatigue biomarkers: HSP90, IL1β, IL6, IL10, IL1βRa, and DNA methylation. |
Countries
Norway
Outcome results
None listed