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

NCT06435091 | Active Not Recruiting

• 3 other identifiers: REBECCA3SUHREBECCA-PROST965231
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Cancer Related Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

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

  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.

  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.

  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.

  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.

  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

Eligibility Criteria

• Age: 19 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients at Stavanger University Hospital, Norway

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, 4067, Norway

Location

Related Links

• REBECCA Project Site

Study Officials

• Svein Skeie, PhD

  Helse Stavanger HF

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: May 30, 2024
• Study Start: December 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

NO (1)