An observational study in Non-Small Cell Lung Cancer (NSCLC), sponsored by Hoffmann-La Roche. Completed at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Hoffmann-La Roche · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 71 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
First line metastatic NSCLC Patients
Participants must meet the following criteria for study entry:
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from study entry:
Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastasis causing nerve impingement) should be treated prior to enrollment. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for locoregional therapy if appropriate prior to enrollment.
Participants with any of the following central nervous system (CNS) metastases:
Severe cardiovascular and pulmonary disease (e.g. myocardial infarction, unstable angina pectoris, coronary angioplasty or stenting, deep vein thrombosis, stroke, pulmonary fibrosis, active uncontrolled bleeding, or a known bleeding diathesis) less than 6 months before inclusion. New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias, or uncontrolled blood pressure.
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.
Device: 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.
Device: 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 (cf. Broderick et al., 2019) for tracking PA, SQ and symptoms for 3 weeks
ECOG-PS assessment of LC participants measured by clinical investigators
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Time frame: From baseline up to 9 months
ECOG-PS assessment of LC participants measured by data collected through wearable and a mobile application
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Time frame: From baseline up to 9 months
Usability of the mobile application perceived by clinical investigators
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.
Time frame: From baseline up to 9 months
Usability of the mobile application perceived by LC participants
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.
Time frame: From baseline up to 9 months
Usability of the wearable device perceived by LC participants
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.
Time frame: From baseline up to 9 months
Usability of the wearable device perceived by clinical investigators
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.
Time frame: From baseline up to 9 months
Sensitivity to changes in ECOG-PS over time measured by clinical investigators
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Time frame: From baseline up to 9 months
Sensitivity to changes in ECOG-PS over time measured by wearable and mobile application
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Time frame: From baseline up to 9 months
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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