Non-Small Cell Lung Cancer (NSCLC)Lupa-01NCT04751162
A Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
An observational study of Non-Small Cell Lung Cancer (NSCLC), run by Hoffmann-La Roche at 10 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Actigraphy device (wearable) and mobile application
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 10 sitesSpain
- Study dates
- 18 Feb 2021to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First line metastatic NSCLC Patients
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Fundacion Hospital de Alcorcon
Alcorcón, Madrid, 28922
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041
Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
Girona, 17007
Hospital Universitario Clínico San Cecilio; Servicio de oncologia
Granada, 18016
Hospital 12 de Octubre; Servicio de Digestivo
Madrid, 28041
Hospital La Paz
Madrid, 28046
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, 30120
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013
Hospital Sant Pau i Santa Tecla; Servicio de Oncologia
Tarragona, 43003
Hospital Universitario la Fe; Servicio de Oncologia
Valencia, 46026
About this study
Official title: An Observational Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
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.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- Actigraphy device (wearable) and mobile application
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actigraphy device (wearable) and mobile applicationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Actigraphy device (wearable) and mobile application | |
| 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:
* 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. Receives: Device: Actigraphy device (wearable) and mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECOG-PS assessment of LC participants measured by clinical investigators
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline up to 9 months
Secondary outcomes (2)
Sensitivity to changes in ECOG-PS over time measured by clinical investigators
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Measured: 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)
Measured: From baseline up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start18 Feb 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751162
- Sponsor's protocol ID
- ML42283
- Acronym
- Lupa-01
- Status last verified
- Jun 2023
- First submitted
- 12 Jan 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
- ClinicalTrials.gov ID
- NCT04751162
- Acronym / sponsor ID
- Lupa-01 / ML42283
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | Device: Actigraphy device (wearable) and mobile applicationParticipants 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. |
| Phase II | – | Device: Actigraphy device (wearable) and mobile applicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First line metastatic NSCLC Patients
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actigraphy device (wearable) and mobile applicationParticipants 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 | Device | Phase I, Phase II |
Primary outcome
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)
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 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.
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.
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 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.
2 secondary outcomes
Sensitivity to changes in ECOG-PS over time measured by clinical investigators
Time frame: From baseline up to 9 months
Sensitivity to changes in ECOG-PS over time measured by wearable and mobile application
Time frame: From baseline up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer (NSCLC), run by Hoffmann-La Roche at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECOG-PS assessment of LC participants measured by clinical investigators (time frame: From baseline up to 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.