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
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Level of fatigue at diagnosis - baseline
研究概览
简要总结
REBECCA-1 is an observational study. Clinical research is undergoing a revolutionary change. The use of electronic patient records (EHR), digital registers, smartphones etc will create "real-world data" (RWD) that provides great opportunities for advancing clinical research, but so far this opportunity has been little exploited. The REBECCA -1 study will observe and monitor fatigue in breast cancer survivors. Investigators will use self reported questionnaires (PROM-data), blood tests and objective regulations like the REBECCCA -1 smart watch that will register amount of steps every day, leaving the house, visiting friends, cafes etc. There will be three observational arms; 1.high fatigue, 2. low fatigue and 3. a healthy control arm. After the patients have finished their treatment, they will receive the REBECCA smart watch, a REBECCA app on the smart phone and a REBECCA plus device on their computer, The next offend are also invited to report their evaluation through the same apps. The observational time will be 1 year and comparison between the subjective PROM data , the objective REBECCA watch and the biological samples will be obtained.
详细描述
Detailed Description:
- 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 . It can also persist for years after completion of treatment in otherwise healthy cancer survivors and studies suggest that up to a third experience persistent fatigue for up to 10 years after being diagnosed with cancer. 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. Various cytokines may be produced during cancer treatment in response to tissue damage from radiation or chemotherapy. Inflammatory candidate biomarkers include Interleukin (IL) 1b, IL6, IL10, IL-17, IL1βRa and IL1-RII 32, 33. Heat shock Protein (HSP) 90 is another current biomarker candidate as it has been shown to reflect the severity of fatigue in patients with Crohn's disease. 2. Rationale behind the REBECCA project
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Breast cancer patients with histologically detectable M0 breast cancer (stage 0-III) who require neoadjuvant or adjuvant endocrine, chemo and / or radiation therapy at least and no more than 3 months before initiation of study.
- •Female breast cancer patients between 19 and 80 years of age.
- •Patients who have increased their 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 an absence of psychological, familial, sociological or geographical condition that potentially impedes compliance with the study protocol and follow-up plan.
- •Exclusion criteria:
- •Male breast cancer patients.
- •Patients who do not agree to the study protocol.
- •Patients with a previous cancer diagnosis (excluding skin cancer treated only by surgery).
- •Patients who have previously been treated with some form of chemotherapy / radiation therapy.
排除标准
- 未提供
结局指标
主要结局
Level of fatigue at diagnosis - baseline
时间窗: This will be done at diagnosis, before treatment.
Visual Analogue Scale (fVAS), which is a score from 0 to 100 mm marked on a 100 mm line on a paper.
Change from baseline fVAS after treatment 6 months
时间窗: 6 months after diagnosis and treatment
fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
fVAS follow up 12 months
时间窗: 12 months after diagnosis and treatment
fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
fVAS follow up 18 months
时间窗: 18 months after diagnosis and treatment
fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
次要结局
- Activity and sleep disorder measured with a smart watch.(This will be measured at month 18)