REBECCA-2 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
- 81
- 试验地点
- 1
- 主要终点
- Quality of life (QoL) measured by the SF36-questionnaire.
研究概览
简要总结
The overall objective of the REBECCA studies at Stavanger University Hospital (SUH) is to improve the QoL of patients affected by cancer-related fatigue during and after end of treatment, by collecting multi-source real world data (RWD) and intervening based on the collected RWD.
In the intervention study, REBECCA-2, the investigators will use the collected real world data to provide a personalised follow-up to the breast cancer patients in order to improve their quality of life. The patients in this study are randomised into 2 groups after end of primary treatment:
- The control group (n=55): Patients will receive standard follow-up according to national guidelines plus 3 generic lifestyle consultation sessions via telephone.
- The experimental REBECCA group (n=55): Patients will, in addition to receiving standard follow-up also receive REBECCA-assisted follow-up. Data will be collected from a REBECCA smartwatch, plug-in and PROMs.
If the REBECCA system detects signs of deterioration in patients' QoL during the study period, the intervention will include changes in medication given, dietary advice, referral to a psychologist/psychiatrist and/or personal training with a physiotherapist at 'Pusterommet' (SUH)
After 12 months of RWD collection participants will be offered the option to continue in the study for another 6 months. For patients in the experimental Rebecca group this includes the use of the REBECCA system for another 6 months. In the clinical REBECCA-2 study, patients' visits are planned every 6 months and include collection of both PROMs and biological samples.
详细描述
- Background:
Clinical research is undergoing revolutionary changes by use of electronic patient records (EHR), digital registers and smartphones. The widespread use of portable devices have led to possibilities to collect "real-world data" (RWD) that provides great opportunities for advancing clinical research.
Fatigue or exhaustion is one of the most common and most annoying late side effects after breast cancer treatment. Cancer Related Fatigue (CRF) may be elevated even before starting treatment and generally increases in intensity during treatment . CRF is multi-dimensional and can have physical, mental and emotional manifestations, including general weakness, decreased concentration or attention, decreased motivation or interest in participating in regular activities, as well as emotional lability. Fatigue has also been shown to have a negative impact on work, social relationships, mood and daily activities and causes a significant reduction in overall quality of life during and after treatment for the patients affected. Thus, studying of RWD in CRF will be an appropriate method and design. As far as known this has not been done before.
The biological mechanisms associated with the development of CRF may involve inflammatory processes contribute to fatigue during and especially after cancer treatment. 2. Rationale behind the REBECCA project:
By using multi-source RWD in clinical studies, it will be possible to monitor the quality of life of patients and have a unique opportunity to map the challenges patients have in their daily lives in terms of work life participation, physical activity, social activity / relationships and their concerns. At the same time, the investigators will explore whether different immunological candidate biomarkers can provide prognostic information related to the development of fatigue in this patient group. 3. Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants have had histologically proven M0 breast cancer (stage 0-II) breast cancer that require neoadjuvant or adjuvant chemo- and/or radio-therapy at least and no more than 3 months pre-study initiation.
- •Age between 19 and 80 years
- •Have increased life expectancy beyond the initial 3 months post-treatment.
- •Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
排除标准
- •Male breast cancer patients
- •Patients that are not willing to sign an informed consent form
- •A previous cancer diagnosis (excluding skin cancers treated by surgery only)
- •Patients previously treated by any form of chemo/radiotherapy.
研究组 & 干预措施
Standard of care
Patients will receive standard follow-up according to national guidelines developed by the Norwegian Breast cancer group (NBCG).
干预措施: Standard follow-up (Other)
Standard of care + REBECCA-assisted intervention
Patients will, in addition to receiving standard follow-up every 6 months, also receive REBECCA-assisted follow-up at frequencies when the REBECCA-system indicate this. The patients will receive a REBECCA smartwatch that they will wear for 12 months. They will also have to install a REBECCA patient app on their mobile and a REBECCA plug-in on their computer for objective RWD collection related to their QoL and lifestyle over the next 12 months. The REBECCA system detects signs of deterioration in patients' QoL during the study period, the intervention will include changes in medication given, dietary advice, referral to a psychologist/psychiatrist and/or personal training with a physiotherapist at 'Pusterommet' (SUH) who will create a personalized training programme, e.g. 2-4 sessions per week.
干预措施: REBECCA-assisted intervention 1 (Drug)
Standard of care + REBECCA-assisted intervention
Patients will, in addition to receiving standard follow-up every 6 months, also receive REBECCA-assisted follow-up at frequencies when the REBECCA-system indicate this. The patients will receive a REBECCA smartwatch that they will wear for 12 months. They will also have to install a REBECCA patient app on their mobile and a REBECCA plug-in on their computer for objective RWD collection related to their QoL and lifestyle over the next 12 months. The REBECCA system detects signs of deterioration in patients' QoL during the study period, the intervention will include changes in medication given, dietary advice, referral to a psychologist/psychiatrist and/or personal training with a physiotherapist at 'Pusterommet' (SUH) who will create a personalized training programme, e.g. 2-4 sessions per week.
干预措施: REBECCA-assisted intervention 2 (Behavioral)
Standard of care + REBECCA-assisted intervention
Patients will, in addition to receiving standard follow-up every 6 months, also receive REBECCA-assisted follow-up at frequencies when the REBECCA-system indicate this. The patients will receive a REBECCA smartwatch that they will wear for 12 months. They will also have to install a REBECCA patient app on their mobile and a REBECCA plug-in on their computer for objective RWD collection related to their QoL and lifestyle over the next 12 months. The REBECCA system detects signs of deterioration in patients' QoL during the study period, the intervention will include changes in medication given, dietary advice, referral to a psychologist/psychiatrist and/or personal training with a physiotherapist at 'Pusterommet' (SUH) who will create a personalized training programme, e.g. 2-4 sessions per week.
干预措施: Standard follow-up (Other)
结局指标
主要结局
Quality of life (QoL) measured by the SF36-questionnaire.
时间窗: Every 6 months, from time of diagnosis to 24-months.
The SF-36 scores the patients physical and mental health on a scale of 0-100, where higher values indicate better health. An increase of 10% or more indicates an improved QoL.
次要结局
- Correlation between the REBECCA system index score and QoL questionnaire score.(At 12 and 18 months from time of diagnosis.)
- Correlation between the REBECCA system index score and fatigue biomarker levels in feces.(At 12 and 18 months from time of diagnosis.)
- Gut microbiota composition in primary breast cancer patients.(Every 6 months, from time of diagnosis to 24-months.)
- Fatigue in primary breast cancer patients measured by the fVAS questionnaire.(Every 6 months, from time of diagnosis to 24-months.)
- Fatigue in primary breast cancer patients measured by the FSS questionnaire.(Every 6 months, from time of diagnosis to 24-months.)
- Effect on fatigue levels after personalized training with a physiotherapist.(Every 6 months, from time of diagnosis to 18-months.)
- Fatigue biomarker HSP90 in plasma of primary breast cancer patients.(Every 6 months, from time of diagnosis to 24-months.)
- REBECCA functional index score at 12-months(At 12-months from time of diagnosis.)
- Correlation between the REBECCA system index score and fatigue biomarker levels in plasma.(At 12 and 18 months from time of diagnosis.)
- Fatigue biomarkers of DNA methylation in plasma of primary breast cancer patients.(Every 6 months, from time of diagnosis to 24-months.)
- REBECCA functional index score at 18-months(At 18-months from time of diagnosis.)
- Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE).(From month 6 - 12)
- Correlation between the REBECCA system index score and fatigue questionnaire scores.(At 12 and 18 months from time of diagnosis.)
- Fatigue in primary breast cancer patients measured by the FQ questionnaire.(Every 6 months, from time of diagnosis to 24-months.)
- Fatigue biomarkers of interleukins (IL) in plasma of primary breast cancer patients.(Every 6 months, from time of diagnosis to 24-months.)