## Protocol Section
### Identification Module
**NCT ID:** NCT06435091

**Acronym:** REBECCA-3

**Brief Title:** 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

#### Organization Study ID Info
**ID:** REBECCA3SUH
#### Organization
**Class:** OTHER_GOV
**Full Name:** Helse Stavanger HF
### Status Module
#### Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-14
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Helse Stavanger HF

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cancer Related Fatigue

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Daily and weekly frequency of participant interactions with the REBECCA system.

**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.

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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

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

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** The REBECCA system index score is given as values between 0 and 100, where higher values indicate higher QoL.

**Measure:** REBECCA system index score

**Time Frame:** At the 4-month post-treatment follow-up.

**Description:** Weekly measurements over a 4-month period.

**Measure:** 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.

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

**Measure:** 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

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

**Measure:** 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

**Description:** REBECCA score (scale 0-100) correlation to the EORTC-QLQ-C30 (scale 0-100), SF36 (scale 0-100), and EPIC-26 (scale 0-100).

**Measure:** Correlation between the REBECCA system index score and QoL questionnaire scores.

**Time Frame:** At the 4-month post-treatment follow-up.

**Description:** REBECCA score (scale 0-100) correlation to the fVAS (scale 0-100), FSS (scale 0-7) and FQ (scale 0-33).

**Measure:** Correlation between the REBECCA system index score and fatigue questionnaire scores.

**Time Frame:** At the 4-month post-treatment follow-up.

**Description:** REBECCA score (scale 0-100) correlation to fatigue biomarker levels of HSP90, IL1β, IL6, IL10, IL1βRa and DNA methylation in plasma.

**Measure:** Correlation between the REBECCA system index score and fatigue biomarker levels in plasma

**Time Frame:** At the 4-month post-treatment follow-up.

**Description:** REBECCA score (scale 0-100) correlation to fatigue biomarker levels of pro-inflammatory and anti-inflammatory microbes in feces.

**Measure:** Correlation between the REBECCA system index score and fatigue biomarker levels in feces.

**Time Frame:** At the 4-month post-treatment follow-up.

**Description:** The System Usability Scale measures user satisfaction on a scale from 0-100, where a score \>75 indicate system use satisfaction.

**Measure:** Subjective assessments of system usability measured by the System Usability Scale questionnaire.

**Time Frame:** At the 4-month post-treatment follow-up.

### Eligibility Module

**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

**Gender Based:** True

**Maximum Age:** 80 Years

**Minimum Age:** 19 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Prostate cancer patients at Stavanger University Hospital, Norway

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tjensvollk@gmail.com

**Name:** Kjersti Tjensvoll, PhD

**Phone:** 004747809206

**Role:** CONTACT

**Contact 2:**

**Email:** sdmn@sus.no

**Name:** Marius Stensland, MD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Stavanger

**Contacts:**

***Contact 1:***

- **Email:** tjensvollk@gmail.com

- **Name:** Kjersti Tjensvoll, PhD

- **Phone:** 004747809206

- **Role:** CONTACT

***Contact 2:***

- **Email:** sdmn@sus.no

- **Name:** Marius Stensland, MD

- **Role:** CONTACT

**Country:** Norway

**Facility:** Stavanger University Hospital

**Status:** RECRUITING

**Zip:** 4067

#### Overall Officials

**Official 1:**

**Affiliation:** Helse Stavanger HF

**Name:** Svein Skeie, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** REBECCA Project Site

**URL:** https://rebeccaproject.eu/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: HIGH

- As Found: Chronic Conditions

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002908

- Term: Chronic Disease

### Misc Info Module

- Version Holder: 2024-05-31
