LIFECHAMPS: A Collective Intelligence Platform to Support Cancer Champions Real-Life Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The LifeChamps Real-Life pilot's objective is to ascertain the feasibility of the use of the LifeChamps solution, previously developed in another clinical trial, in a real-world environment. This solution integrates a health advisory system, and technical intelligence, based on behavioural science, to provide personalized recommendations to follow a healthier lifestyle, to act as a nutrition and physical activity coach, and to guide on social inclusion, among other issues, with the aim of increasing the quality of life. This study is conducted to investigate the feasibility of such an undertaking, assess the clinical impact it may have, as well as evaluate the applicability, usability, and effectiveness of the solution.
详细描述
"The LifeChamps project (https://lifechamps.eu/) is creating a digital platform to support clinical teams to provide more integrated follow-up care to older patients with cancer. The digital platform will integrate data coming directly from the patient (patient-reported outcomes and sensor data from wearable devices), from the home environment (home sensors, weight scales), and from the clinical environment (data routinely collected via the Electronic Health Record). The digital platform will use big data analytics (machine learning) to process all data as part of predictive clinical algorithms for frailty and quality of life for older patients with cancer. Development of each clinical algorithm requires that the prototype model (or analytics engine) is trained using abundant real-world data to help consolidate the predictive ability and validity of the algorithms before the algorithms are deployed in a larger scale feasibility trial.
A pre-post design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months.
The main research questions of the study are:
- Is patient recruitment possible in terms of numbers and rates within the recruitment period?
- Is participant retention in the study possible in terms of numbers and rates?
- Do participants adhere to the protocol?
- What are the views/experiences of study participants (patients and healthcare professionals) using the Lifechamps solution (mHealth app and dashboard respectively)?
- What is the adherence with the usage of the different digital health patients' tools (e.g., usage of mHealth app, smartwatch, smart weight scale)?
Healthcare professionals related to oncology (oncologists, nurses etc.) will also be recruited to use the LifeChamps dashboard and evaluate its usefulness, usability and acceptability. They will have access to and asked to use the LC Dashboard. The LC Dashboard will provide pseudonymised information regarding the patients' physical activity and PROMs for the purpose of the pilot feasibility trial. They will not be able to view real time processed information. After the patients have exited the study, the HCPs will be shown the anonymised outputs of the engine per patient and asked their opinions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast or prostate cancer.
- •Diagnosed with early stage (I-III) cancer (breast, prostate) and living beyond initial cancer treatment (curative/incurable).
- •Diagnosed with advanced or metastatic disease with life expectancy >12 months.
- •At least 1 month after a) local treatment with curative intent (surgery, radiotherapy) or b) initiation of systemic treatment (hormone treatment, CDK4/6 or new generation antiandrogens).
- •Absence of diagnosed secondary malignancy.
- •Deemed by a member of the multidisciplinary team as physically and psychologically fit to participate in the study.
- •Able to read, write and understand the respective local language (greek).
- •Achieve a score of above 2 on the Mini-Cog during the screening process.
- •Able to bring and use own Android version 10 (or above) device during the study.
- •Domestic 24/7 internet access via wi-fi and/or 4G mobile data (will be provided if unavailable).
排除标准
- •Currently receiving chemotherapy.
- •Terminal cancer stage on palliative care.
- •Survival prognosis of <18 months from the time of recruitment.
- •Unwilling to provide written informed consent.
- •Presence of internal medical device (e.g. pacemaker etc.)
结局指标
主要结局
Recruitment rate
时间窗: 7 months
This outcome will be calculated by dividing the number of participants consented over the number of approached participants. It is a ratio between 0 and 1, with 1 being the best outcome.
Participant retention rate
时间窗: 7 months
This outcome will be calculated by dividing the number of participants that finished the study over the number of participants that entered the study. It is a ratio between 0 and 1, with 1 being the best outcome.
Technology Adherence rate
时间窗: 7 months
This outcome will be calculated by dividing the number of times the technology was used over the maximum times that technology can be used over the course of the study. It is a ratio between 0 and 1, with 1 being the best outcome.
次要结局
- Quality of life Assessment(3 months)
- Functional Assessment(3 months)
- Frailty(3 months)
- Quality of Life Utility Measure(3 months)
研究者
Panos Bamidis
Professor
Aristotle University Of Thessaloniki