REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of the average REBECCA system usage rate throughout the monitoring period.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Evaluation of the average REBECCA system usage rate throughout the monitoring period.
时间窗: From the end of treatment to the 4-month post-treatment follow-up.
Daily and weekly frequency of participant interactions with the REBECCA system.
次要结局
- Subjective assessments of system usability measured by the System Usability Scale questionnaire.(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)
- 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)
- Correlation between the REBECCA system index score and fatigue biomarker levels in plasma(At the 4-month post-treatment follow-up.)
- Correlation between the REBECCA system index score and fatigue biomarker levels in feces.(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)
- REBECCA system index score(At the 4-month post-treatment follow-up.)
- 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)
- 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)
- Gut microbiota composition in primary prostate cancer patients.(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.(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)
- Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE)(From the end of treatment to the 4-month post-treatment follow-up.)
- Fatigue biomarkers in plasma of primary prostate cancer patients.(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.(At the 4-month post-treatment follow-up.)
- Correlation between the REBECCA system index score and fatigue questionnaire scores.(At the 4-month post-treatment follow-up.)