Cancer Related FatigueREBECCA-3NCT06435091
REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
An observational study of Cancer Related Fatigue, run by Helse Stavanger HF at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 19 to 80 years, men only
- Conditions the study is for
- Cancer Related Fatigue
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 15 Dec 2023to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate cancer patients at Stavanger University Hospital, Norway
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer Related Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the average REBECCA system usage rate throughout the monitoring period.
Daily and weekly frequency of participant interactions with the REBECCA system.
Measured: From the end of treatment to the 4-month post-treatment follow-up.
Secondary outcomes (15)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
REBECCA system index score
The REBECCA system index score is given as values between 0 and 100, where higher values indicate higher QoL.
Measured: At the 4-month post-treatment follow-up.
Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE)
Weekly measurements over a 4-month period.
Measured: From the end of treatment to the 4-month post-treatment follow-up.
Fatigue biomarkers in plasma of primary prostate cancer patients.
Measure levels of fatigue biomarkers: HSP90, IL1β, IL6, IL10, IL1βRa, and DNA methylation.
Measured: 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
Gut microbiota composition in primary prostate cancer patients.
Long-read 16S rRNA sequencing of faecal samples to characterize the gut microbiota composition.
Measured: 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
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).
Measured: At the 4-month post-treatment follow-up.
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).
Measured: At the 4-month post-treatment follow-up.
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, IL1β, IL6, IL10, IL1βRa and DNA methylation in plasma.
Measured: At the 4-month post-treatment follow-up.
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.
Measured: At the 4-month post-treatment follow-up.
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.
Measured: At the 4-month post-treatment follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start15 Dec 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Svein Skeie, PhD, Study director, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435091
- Sponsor's protocol ID
- REBECCA3SUH
- Other IDs
- REBECCA-PROST, 965231
- Acronym
- REBECCA-3
- Status last verified
- May 2025
- First submitted
- 14 Mar 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stensland M, Bru KF, Austdal M, Dahl IH, Jonsdottir K, Lende TH, Heimvik C, Elve I, Omdal R, van der Giezen M, Kvivik I, Tangeland B, Davidsen L, Hashemi M, Cais A, van Dijk KJ, Seyoum Y, Blafjelldal V, Sola ST, Papadopoulos A, Kiriakidou N, Ioakeimidis I, Diou C, Sarafis I, Delopoulos A, Janssen EAM, Gilje B, Tjensvoll K. Monitoring cancer-related fatigue and quality of life in breast and prostate cancer patients after primary treatment: a study protocol for the REBECCA trials in Norway. Clin Exp Med. 2026 Feb 8;26(1):133. doi: 10.1007/s10238-026-02073-y.
PubMed 41655181
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
- ClinicalTrials.gov ID
- NCT06435091
- Acronym / sponsor ID
- REBECCA-3 / REBECCA3SUH
- Conditions
- Cancer Related Fatigue
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients at Stavanger University Hospital, Norway
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
15 secondary outcomes
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
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
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
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
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
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
REBECCA system index score
Time frame: At the 4-month post-treatment follow-up.
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.
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
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
Correlation between the REBECCA system index score and QoL questionnaire scores.
Time frame: At the 4-month post-treatment follow-up.
Correlation between the REBECCA system index score and fatigue questionnaire scores.
Time frame: At the 4-month post-treatment follow-up.
Correlation between the REBECCA system index score and fatigue biomarker levels in plasma
Time frame: At the 4-month post-treatment follow-up.
Correlation between the REBECCA system index score and fatigue biomarker levels in feces.
Time frame: At the 4-month post-treatment follow-up.
Subjective assessments of system usability measured by the System Usability Scale questionnaire.
Time frame: At the 4-month post-treatment follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41655181Stensland M, Bru KF, Austdal M, Dahl IH, Jonsdottir K, Lende TH, Heimvik C, Elve I, Omdal R, van der Giezen M, Kvivik I, Tangeland B, Davidsen L, Hashemi M, Cais A, van Dijk KJ, Seyoum Y, Blafjelldal V, Sola ST, Papadopoulos A, Kiriakidou N, Ioakeimidis I, Diou C, Sarafis I, Delopoulos A, Janssen EAM, Gilje B, Tjensvoll K. Monitoring cancer-related fatigue and quality of life in breast and prostate cancer patients after primary treatment: a study protocol for the REBECCA trials in Norway. Clin Exp Med. 2026 Feb 8;26(1):133. doi: 10.1007/s10238-026-02073-y.
- REBECCA Project SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svein Skeie, PhD study director
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Related Fatigue, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06435091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.