An Observational Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 71
- Locations
- 10
- Primary Endpoint
- ECOG-PS assessment of LC participants measured by data collected through wearable and a mobile application
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
ECOG-PS assessment of LC participants measured by data collected through wearable and a mobile application
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Sensitivity to changes in ECOG-PS over time measured by wearable and mobile application(From baseline up to 9 months)
- Sensitivity to changes in ECOG-PS over time measured by clinical investigators(From baseline up to 9 months)