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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I | 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. |
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| Phase II | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actigraphy device (wearable) and mobile application | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ECOG-PS assessment of LC participants measured by clinical investigators | ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982) | 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) | 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. | 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. | 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. | From baseline up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity to changes in ECOG-PS over time measured by clinical investigators | ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982) | From baseline up to 9 months |
| Sensitivity to changes in ECOG-PS over time measured by wearable and mobile application |
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Inclusion Criteria
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.
Pregnant or breastfeeding woman.
Leptomeningeal disease.
Participants with any of the following central nervous system (CNS) metastases:
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to study entry.
Oncological history:
Have a previous or concurrent cancer that is distinct in primary (non-pulmonary) site or histology, except carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated with last specific treatment more than 3 years ago without evidence of recurrence.
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent).
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.
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First line metastatic NSCLC Patients
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Hospital de Alcorcon | Alcorcón | Madrid | 28922 | Spain | ||
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia |
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| 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. |
| From baseline up to 9 months |
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982) |
| From baseline up to 9 months |
| Barcelona |
| 08041 |
| Spain |
| Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica | Girona | 17007 | Spain |
| Hospital Universitario Clínico San Cecilio; Servicio de oncologia | Granada | 18016 | Spain |
| Hospital 12 de Octubre; Servicio de Digestivo | Madrid | 28041 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | 30120 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Hospital Sant Pau i Santa Tecla; Servicio de Oncologia | Tarragona | 43003 | Spain |
| Hospital Universitario la Fe; Servicio de Oncologia | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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