LIFECHAMPS: A Collective Intelligence Platform to Support Cancer Champions Small-Scale Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Analytical models
研究概览
简要总结
The aim of this study is to facilitate collection of real-world data to test and train the analytics engine for each prototype algorithm. Preliminary datasets will be generated to enable a dry run of the prototype algorithms to check their predictive functionality as part of simulated 'experimental' scenarios at each LifeChamps partner site. This preparatory work will be critical to the development of the LifeChamps platform, prior to progressing to a larger scale feasibility trial.
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 prospective, time series design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months.
Older patients with a cancer diagnosis will be the target population for this study. Consecutive sampling will be used, whereby all older patients with cancer who meet the eligibility criteria will be approached and invited in the study. Each study participant will be involved in the study for 3 months in total. A 3-month recruitment period will be allowed, bringing the total study duration to 6 months (from first patient being enrolled until last patient finishing data collection).
AUTH: Patients aged 65 years and above, diagnosed with early-stage breast or prostate cancer will be identified at the Department of Medical Oncology at G. Genimatas General Hospital, "Alma Zois" a non-profit association of women who had experienced breast cancer based in Thessaloniki, Greece and collaborating private clinics. The patients will be presented with the opportunity to participate in the study and screened based on the inclusion and exclusion criteria. Potential participants will be provided with the information sheet and the consent form, informed that should they decline to participate this will not change their current treatment and provided the opportunity to ask any questions they may have.
Region Stockholm : Melanoma survivors aged 65 years and above, who have completed primary treatment within the last 12 months prior to the study, will be identified by our clinical partners within primary and secondary care in Region Stockholm. Online advertisements for the study will also be disseminated and participants may be recruited through LifeChamps partners (e.g. Karolinska Institute) or the Swedish melanoma patient association (Melanomföreningen) which will direct them to an online recruitment form within Region Stockholm. The researchers will then make a follow-up call to confirm interest in study participation. During the contact, the melanoma survivor will be asked to provide their written consent or decline participation and ask for a second contact before his/her final decision. All declining melanoma survivors will be thanked for their time and reassured that their decision will have no impact on their current or future treatment and care. All consenting participants will be reassured that they can withdraw at any time that they desire from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
Analytical models
时间窗: 6 months
The collected data will be used to train and test the analytical models. For example, the initial data from sensors will be refined, further, with statistical, spectral and supervised learning analyses to identify and extract possible patterns (e.g., activities of daily living) inside their signals. Sensor, EHR and PROM data will be all analysed together through exploratory algorithms (e.g., pairwise Markov random fields, Bayesian networks) to identify possible interactions and dependencies among their trajectories, mapping the frailty and QOL domains of elderly prostate and breast cancer patients across all the data collection process.
次要结局
- Quality of Life assessment(3 months)
- Prostate cancer symptoms(3 months)
- Symptoms(3 months)
- Medication Adherence(3 months)
- Quality of Life due to Urinary symptoms(3 months)
- Frailty(3 months)
- Erectile Dysfunction(3 months)
- Anxiety and Depression(3 months)
- Illness perception(3 months)
研究者
Panos Bamidis
Professor
Aristotle University Of Thessaloniki
