A Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.

Completed

• Conditions: Non-Small Cell Lung Cancer (NSCLC)

• 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

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-11
• Study Start: 2021-02-18
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

Fundacion Hospital de Alcorcon; 🇪🇸 Alcorcon, Madrid, Spain

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia; 🇪🇸 Barcelona, Spain

Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica; 🇪🇸 Girona, Spain

Hospital Universitario Clínico San Cecilio; Servicio de oncologia; 🇪🇸 Granada, Spain

Hospital 12 de Octubre; Servicio de Digestivo; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia; 🇪🇸 Murcia, Spain

Hospital Universitario Virgen del Rocio; Servicio de Oncologia; 🇪🇸 Sevilla, Spain

Hospital Sant Pau i Santa Tecla; Servicio de Oncologia; 🇪🇸 Tarragona, Spain

Hospital Universitario la Fe; Servicio de Oncologia; 🇪🇸 Valencia, Spain