LifeChamps Feasibility Study

NCT05990634 | Unknown

• 2 other identifiers: X00568GA875329
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma (Skin)

Keywords

Melanoma; Cancer; Survivorship; Quality of Life; mHealth application; Wearables; Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

• Analytical models

  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.

  3 to 6 Months

• Usability assessment

  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.

  3 to 6 Months

Secondary Outcomes (3)

• QoL assessment

  3 to 6 Months

• Fear of Cancer Recurrency (FCRI)

  3 to 6 Months

• Sun Exposure and Protection Index (SEPI)

  3 to 6 Months

Other Outcomes (2)

• Retention and adherence to study protocol

  9 to 12 Months

• Technology adherence

  3 to 6 Months

Study Arms (1)

LifeChamps Platform

EXPERIMENTAL

Participants will be asked to use the LifeChamps platform and will be provided with the study equipment (sensors/home kit).

Device: LifeChamps Platform

Interventions

LifeChamps Platform DEVICE

Participants will be provided with the study equipment, i.e., a mobile app, smartwatch, smart t-shirt, smart scale, location home sensor, and a micro-computer, with which they will need to interact with the devices for three months in the respective study phase (pre-pilot/feasibility trial). Specifically, participants should wear the activity tracker wristband (Fitbit Charge 4) as much as possible. The smart t-shirt should as well be worn daily as much as possible. Additionally, participants should use the smart scale to weigh themselves and the mobile app to fill in selected PROMs monthly, while the ambient home sensors (location home sensor (LOCS) and smart plug) will be passively collecting information about their everyday living during these three months. Lastly, participants' clinical and demographic data from the local EHRs will be collected.

LifeChamps Platform

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead
• Aristotle University Of Thessaloniki: collaborator
• Hospital Universitario La Fe: collaborator
• University of Glasgow: collaborator

Study Sites (1)

Academic Primary Health Care Centre

Stockholm, 11863, Sweden

Location

Related Links

• Project website

MeSH Terms

Conditions

Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Panagiotis Papachristou, MD/PhD

  Region Stockholm, Academic Primary Health Care Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: August 14, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)