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NCT Number: NCT06435091

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

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.

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Key information

Conditions

Cancer Related Fatigue

Age range

19 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Stavanger University Hospital

Stavanger, 4067, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Quality of life (QoL) measured by the EORTC-QLQ-C30.

    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

    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.

  2. Quality of life (QoL) measured by the SF36-questionnaire.

    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

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

  3. Quality of life (QoL) measured by the EPIC-26-questionnaire.

    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

    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.

  4. Fatigue in primary prostate cancer patients measured by the fVAS questionnaire.

    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

    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.

  5. Fatigue in primary prostate cancer patients measured by the FSS questionnaire.

    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

    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.

  6. Fatigue in primary prostate cancer patients measured by the FQ questionnaire.

    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

    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.

  7. REBECCA system index score

    Time frame: 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.

  8. Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE)

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

    Weekly measurements over a 4-month period.

  9. Fatigue biomarkers in plasma of primary prostate cancer patients.

    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

    Measure levels of fatigue biomarkers: HSP90, IL1β, IL6, IL10, IL1βRa, and DNA methylation.

  10. Gut microbiota composition in primary prostate cancer patients.

    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

    Long-read 16S rRNA sequencing of faecal samples to characterize the gut microbiota composition.

  11. Correlation between the REBECCA system index score and QoL questionnaire scores.

    Time frame: 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).

  12. Correlation between the REBECCA system index score and fatigue questionnaire scores.

    Time frame: 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).

  13. Correlation between the REBECCA system index score and fatigue biomarker levels in plasma

    Time frame: 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.

  14. Correlation between the REBECCA system index score and fatigue biomarker levels in feces.

    Time frame: 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.

  15. Subjective assessments of system usability measured by the System Usability Scale questionnaire.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Acronym: REBECCA-3

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 30, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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