Clinical trial NCT04751162: A Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
Official title: An Observational Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-02-11
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First line metastatic NSCLC Patients

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.


Eligibility criteria: Inclusion Criteria

Participants must meet the following criteria for study entry:

* 18 or more years of age.
* Able to understand and provide the study informed consent.
* Able to demonstrate basic digital literacy (e.g. knows how to communicate through instant messaging apps or similar).
* ECOG PS of 0, 1 or 2 assessed by physician.
* Life expectancy ≥ 12 weeks
* Histopathologically or cytologically confirmed Non-small cell lung cancer (NSCLC) according to the International Association for the Study of Lung Cancer (IASLC) histopathological classification. Mixed or combined subtypes with component of small cell lung cancer according to the IASLC are not allowed.
* Metastatic NSCLC participants.
* Able to receive 1st line specific antitumor therapy defined by local practice and decision of attended oncologist.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from study entry:

* Any medical or social condition deemed by the investigator to be likely to interfere with a participant's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
* Participants with advanced LC and a known sensitizing driver mutation: activating EGFR mutation, ALK gene rearrangement, ROS1+ gen rearrangement, BRAF mutation.
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

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:

  * Symptomatic CNS metastases with need of increasing doses of corticosteroids.
  * Carcinomatous meningitis.
* 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.

* Any psychiatric diagnosis.
* Observed cognitive impairment or disease with cognitive impairment such as Alzheimer's Disease or Parkinson's Disease
* Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
* Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
* Inability to understand the local language.
* Allergic to dedicated wearable material.
* Currently enrolled in a Clinical Trial.

Primary outcomes:
measure: ECOG-PS assessment of LC participants measured by clinical investigators
timeFrame: From baseline up to 9 months
measure: ECOG-PS assessment of LC participants measured by data collected through wearable and a mobile application
timeFrame: From baseline up to 9 months
measure: Usability of the mobile application perceived by clinical investigators
timeFrame: From baseline up to 9 months
measure: Usability of the mobile application perceived by LC participants
timeFrame: From baseline up to 9 months
measure: Usability of the wearable device perceived by LC participants
timeFrame: From baseline up to 9 months
measure: Usability of the wearable device perceived by clinical investigators
timeFrame: From baseline up to 9 months
Secondary outcomes:
measure: Sensitivity to changes in ECOG-PS over time measured by clinical investigators
timeFrame: From baseline up to 9 months
measure: Sensitivity to changes in ECOG-PS over time measured by wearable and mobile application
timeFrame: From baseline up to 9 months
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon
state: Madrid
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio; Servicio de oncologia
city: Madrid
country: Spain
facility: Hospital 12 de Octubre; Servicio de Digestivo
city: Madrid
country: Spain
facility: Hospital La Paz
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
city: Tarragona
country: Spain
facility: Hospital Sant Pau i Santa Tecla; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Oncologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: