Clinical trial NCT06435091: REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
Official title: REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer Related Fatigue
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2024-05-30
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients at Stavanger University Hospital, Norway

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the average REBECCA system usage rate throughout the monitoring period.
timeFrame: From the end of treatment to the 4-month post-treatment follow-up.
Secondary outcomes:
measure: Quality of life (QoL) measured by the EORTC-QLQ-C30.
timeFrame: 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: Quality of life (QoL) measured by the SF36-questionnaire.
timeFrame: 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: Quality of life (QoL) measured by the EPIC-26-questionnaire.
timeFrame: 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: Fatigue in primary prostate cancer patients measured by the fVAS questionnaire.
timeFrame: 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: Fatigue in primary prostate cancer patients measured by the FSS questionnaire.
timeFrame: 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: Fatigue in primary prostate cancer patients measured by the FQ questionnaire.
timeFrame: 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: REBECCA system index score
timeFrame: At the 4-month post-treatment follow-up.
measure: Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE)
timeFrame: From the end of treatment to the 4-month post-treatment follow-up.
measure: Fatigue biomarkers in plasma of primary prostate cancer patients.
timeFrame: 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: Gut microbiota composition in primary prostate cancer patients.
timeFrame: 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: Correlation between the REBECCA system index score and QoL questionnaire scores.
timeFrame: At the 4-month post-treatment follow-up.
measure: Correlation between the REBECCA system index score and fatigue questionnaire scores.
timeFrame: At the 4-month post-treatment follow-up.
measure: Correlation between the REBECCA system index score and fatigue biomarker levels in plasma
timeFrame: At the 4-month post-treatment follow-up.
measure: Correlation between the REBECCA system index score and fatigue biomarker levels in feces.
timeFrame: At the 4-month post-treatment follow-up.
measure: Subjective assessments of system usability measured by the System Usability Scale questionnaire.
timeFrame: At the 4-month post-treatment follow-up.
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Svein Skeie, PhD
role: STUDY_DIRECTOR
References: