跳至主要内容
临床试验/NCT05990634
NCT05990634进行中(未招募)不适用

LIFECHAMPS: A Collective Intelligence Platform to Support Cancer Champions - Stockholm Pilot Use Case 2

Region Stockholm2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Analytical models

研究概览

简要总结

The purpose of this study is to collect data from various sources (PROM / PREM, sensors, journal data) to train AI based models in the LifeChamps digital platform in a pre-pilot, as well as partly implement a pilot/feasibility study to examine the applicability of the digital technology developed in LifeChamps, as well as the usability for patients (cancer survivors) and health care professionals

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 the feasibility trial.

A prospective, time series design will be employed, whereby the LifeChamps platform will be deployed first during the pre-pilot in a total of 3 months; later in an interrupted time series feasibility trial during a period of 5 months.

Older patients with a cancer diagnosis (specifically melanoma) 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 or 5 months in total respectively. A 3-month recruitment period will be allowed and is overlapping with the two studies, bringing the total study duration to 6 months (from first patient being enrolled until last patient finishing data collection).

Patients aged 65 years and above, diagnosed with stage I-III melanoma skin cancer will be identified from Region Stockholm participating primary care facilities and the Melanoma patient association (Melanomföreningen) . 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.

After written informed consent has been provided, the mini-COG will be used to evaluate study participants' cognitive function and impairment at baseline. The mini-COG consists of a 3-word recall and a clock-drawing test, and can be completed within 5 minutes. A score of less than 3/5 indicates the need to refer the patient for full cognitive assessment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Diagnosed with malignant melanoma (stage I-III) and undergone primary treatment within the last 36 months.
  • Has completed primary and secondary cancer treatment and is now in remission (survivorship stage).
  • Assessed as physically and mentally able to participate in the study
  • Can read, write and understand the Swedish language
  • Can bring and use their own smart phone (Android version 10 or newer) below the study
  • Have 24-hour access to internet (broadband) via WiFi router in your own household and/or free 4G mobile data (sim card and 4G router will be provided if this criterion is not met)

排除标准

  • Terminal cancer stage or prognosis <18 months from time of recruitment
  • Diagnosed with severe mental illness or cognitive illness that affects the ability to participate
  • Screening with Mini-Cog where the result is between 0-2
  • Inability or unwillingness to provide written informed consent

结局指标

主要结局

Analytical models

时间窗: 3 to 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 melanoma cancer patients across all the data collection process.

Usability assessment

时间窗: 3 to 6 Months

The usability of the LifeChamps platform will be measured through the System Usability Scale questionnaire with Likert type questions from 1 to 5, where 5 is strongly agree and 1 is strongly disagree on the ten statements of the SUS questionnaire.

次要结局

  • Sun Exposure and Protection Index (SEPI)(3 to 6 Months)
  • Fear of Cancer Recurrency (FCRI)(3 to 6 Months)
  • QoL assessment(3 to 6 Months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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