Real-Life Pilot Feasibility Study (LC_RLP)

NCT05797727 | Completed

• 1 other identifier: 875329B
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Prostate Cancer

Keywords

Cancer; mHealth App; Ambient Sensors; Wearables; Smartwatch; Smart scale; Analytics Engine

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  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.

  7 months

• Participant retention rate

  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.

  7 months

• Technology Adherence rate

  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.

  7 months

Secondary Outcomes (4)

• Quality of life Assessment

  3 months

• Functional Assessment

  3 months

• Frailty

  3 months

• Quality of Life Utility Measure

  3 months

Other Outcomes (2)

• Perceived Acceptability

  3 months

• Perceived Usability

  3 months

Study Arms (2)

LifeChamps Platform

EXPERIMENTAL

Participants will be asked to use the LifeChamps platform and will be provided with the study equipment.

Device: LifeChamps Platform

LifeChamps Platform HCP

EXPERIMENTAL

Participating Healthcare professionals will be asked to use the LifeChamps Dashboard

Device: LifeChamps Platform HCP

Interventions

LifeChamps Platform HCP DEVICE

Healthcare professionals that will participate in the study will be introduced will have access to the LifeChamps Dashboard, which will display the data monitored from the patients, thus potentially facilitating patients' follow-up between clinical consultations. 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, such as risk of frailty, QoL, risk of dependency and psychological condition, from the LIFECHAMPS analytics engine. They will be shown the anonymised outputs of the engine per patient and asked their opinions on the usability, acceptability and on whether such information would have helped better manage their patients' supportive care.

LifeChamps Platform HCP

LifeChamps Platform DEVICE

Participants will be asked to provide 5 endpoints (PROMS) and will be provided with the study equipment, i.e., a mobile app, smartwatch, smart scale, location home sensor, a smart plug, and a micro-computer, with which they will need to interact with the devices for three months. Specifically, participants should wear the activity tracker wristband (Fitbit Charge 4) 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 will be passively collecting information about their everyday living during these three months. At the end of the 3 month period, the participants will return the devices and will be asked to provide the 5 endpoints and their opinions regarding the usability and acceptability of the platform using structured questionnaires

LifeChamps Platform

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.)

Sponsors & Collaborators

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

Study Sites (1)

Laboratory of Medical Physics and Digital Innovation, AUTH

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Panos D Bamidis, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel: Clinical trials with a two arms: A prospective, pre-post design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: January 15, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 6, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available 5 years after the end of the study for indefinite period of time.
• Access Criteria: Data will be made available only for non-commercial research purposes.

Locations

GR (1)