A Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- Device: Actigraphy device (wearable) and mobile application
- Registration Number
- NCT04751162
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The current research is a non-interventional (NIS) study seeking to support objective Performance Status (PS) assessments in the particular context of metastatic NSCLC adult patients. To do so, the study comprises two phases. Phase I addresses a feasibility mixed-methods (quantitative-qualitative) approach. It primarily focuses on examining perceived technology usability in a limited sample of participants and feasibility of translating the actigraph data into PS scores (focus expert group). Phase II focuses on to primarily examine associations between technology collected data and ECOG-PS in a larger sample of participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Phase II Actigraphy device (wearable) and mobile application Participants will be equipped with both devices (wearable and mobile application) for further monitoring during the following 9 weeks. Study participants will undergo scheduled visits according to local standard practice. The study will progress to Phase II just in case any of the following conditions are met at the end of Phase I: * The average time of use of the wearable device is equal or over 96 hours/week/participant, OR * The average SUS score is equal or above 68, OR * The average adherence to the app is equal or above 80%, measured as the rate of submitted ePROMs through the app. Phase I Actigraphy device (wearable) and mobile application Participants will be asked to wear an actigraphy device (wearable) and to install a mobile application on their smartphones for tracking PA, SQ and symptoms for 3 weeks The ECOG-PS will be assessed by clinician at both, baseline and subsequent visit after the 3 weeks.
- Primary Outcome Measures
Name Time Method ECOG-PS assessment of LC participants measured by data collected through wearable and a mobile application From baseline up to 9 months ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Usability of the wearable device perceived by clinical investigators From baseline up to 9 months System Usability: SUS questionnaire (Brooke, 1986) and usability questionnaire adapted from (Kim et al., 2017). This is a 10-item scale based on a 5-point Likert response measuring strength and agreement of usability. Total scores range from 0 to 100 with score = 68 considered acceptable usability.
Usability of the wearable device perceived by LC participants From baseline up to 9 months System Usability: SUS questionnaire (Brooke, 1986) and usability questionnaire adapted from (Kim et al., 2017). This is a 10-item scale based on a 5-point Likert response measuring strength and agreement of usability. Total scores range from 0 to 100 with score = 68 considered acceptable usability.
Usability of the mobile application perceived by clinical investigators From baseline up to 9 months System Usability: SUS questionnaire (Brooke, 1986) and usability questionnaire adapted from (Kim et al., 2017). This is a 10-item scale based on a 5-point Likert response measuring strength and agreement of usability. Total scores range from 0 to 100 with score = 68 considered acceptable usability.
ECOG-PS assessment of LC participants measured by clinical investigators From baseline up to 9 months ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Usability of the mobile application perceived by LC participants From baseline up to 9 months System Usability: SUS questionnaire (Brooke, 1986) and usability questionnaire adapted from (Kim et al., 2017). This is a 10-item scale based on a 5-point Likert response measuring strength and agreement of usability. Total scores range from 0 to 100 with score = 68 considered acceptable usability.
- Secondary Outcome Measures
Name Time Method Sensitivity to changes in ECOG-PS over time measured by wearable and mobile application From baseline up to 9 months ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Sensitivity to changes in ECOG-PS over time measured by clinical investigators From baseline up to 9 months ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Trial Locations
- Locations (10)
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
🇪🇸Girona, Spain
Fundacion Hospital de Alcorcon
🇪🇸Alcorcon, Madrid, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
🇪🇸Murcia, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
🇪🇸Barcelona, Spain
Hospital 12 de Octubre; Servicio de Digestivo
🇪🇸Madrid, Spain
Hospital Sant Pau i Santa Tecla; Servicio de Oncologia
🇪🇸Tarragona, Spain
Hospital Universitario ClÃnico San Cecilio; Servicio de oncologia
🇪🇸Granada, Spain
Hospital Universitario la Fe; Servicio de Oncologia
🇪🇸Valencia, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
🇪🇸Sevilla, Spain