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. |
|