Nonsmall Cell Lung CancerLuCAppNCT03512015
A Mobile Supportive Care App for Patients With Metastatic Lung Cancer
A study testing The Lung Cancer App - LuCApp in people with Nonsmall Cell Lung Cancer and Small Cell Lung Carcinoma, run by Bocconi University.
Trial summary
Self-management interventions can help patients and their families care for themselves along the cancer care continuum. This scenario has witnessed the rapid and ongoing growth in mobile technologies, including mobile health (mHealth). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer, Small Cell Lung Carcinoma
- What is being tested?
- The Lung Cancer App - LuCApp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2018to 30 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- over 18 years of age individuals of both sexes;
- diagnosed with small or non-small cell lung cancer;
- patients eligible for chemotherapy, immunotherapy or biological therapy;
- patients diagnosed with non-resectable tumor and eligible for neoadjuvant therapies;
- life expectancy of six months or more;
- a performance status between 0 (asymptomatic) and 2 (symptomatic, <50% in bed during the day) according to the Eastern Cooperative Oncology Group (ECOG) score;
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- patients fluently speaking Italian;
- patients able to provide informed consent to participate in the study;
- patients who own a smartphone that can access either the iOS or the Android platform.
Who cannot join
- individuals unable to provide written informed consent;
- individuals unable to see the App and all other materials (i.e. are blind);
- patients receiving or that plan to receive radiotherapy or surgical resection;
- patients already included or about to join other clinical trials;
- patients already using other smartphone applications to self-manage cancer symptoms.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Mobile Supportive Care App for Patients With Metastatic Lung Cancer: a Pilot Randomized Controlled Trial - The Lung Cancer App (LuCApp) Study
Self-management interventions can help patients and their families care for themselves along the cancer care continuum. This scenario has witnessed the rapid and ongoing growth in mobile technologies, including mobile health (mHealth). LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals. This is a 24-week, two-arm, non-blinded multicenter feasibility parallel randomized controlled trial aimed to evaluate the usability and effectiveness of LuCApp vs standard care to improve self-management of symptoms and health related quality of life in lung cancer patients.
Read the detailed description
Background: Self-management interventions can help patients and their families care for themselves along the cancer care continuum. This scenario has witnessed the rapid and ongoing growth in mobile technologies, including mobile health (mHealth). LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals.
Objectives: To evaluate the usability and effectiveness of LuCApp vs standard care to improve self-management of symptoms and health related quality of life in lung cancer patients.
Design: This is a 24-week, two-arm, non-blinded multicenter feasibility parallel randomized controlled trial.
Patient population: Adults of both sexes diagnosed with small or non-small cell lung cancer, eligible for pharmaceutical treatments with good performance status and life expectancy of ≥6 months or more, fluently speaking Italian and able to use a smartphone will be eligible for recruitment. Participants will remain on study until discontinuation of cancer treatment, voluntary withdrawal, study termination or death.
Intervention and comparator: Consenting patients will be assigned in a 1:1 randomized way to receiving either standard care or LuCApp in addition to standard care. During the treatment period, LuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met.
Outcomes: The primary outcome is the change in the score of the Trial Outcome Index (TOI) in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks. A battery of patient-reported outcomes measures will also be assessed: the Lung Cancer Subscale, the EuroQoL 5D questionnaire, the Hospital Anxiety and Depression Scale, the Supportive Care Needs Survey Short Form, the app usability questionnaire and resource use. The Zarit Burden interview will be assessed with the main caregiver.
Conclusions: The electronic and mobile health revolution holds great potentials for improving symptom management strategies in chronic conditions, hence the evaluation of such interventions becomes important in order to bring to patients and to healthcare systems effective and cost-effective solutions. This pilot trial was designed with a pragmatic attitude to test the feasibility of LuCApp, as a technology to improve self-reporting and self-management of symptoms in patients with lung cancer, on health related quality of life and usability.
- Being tested
- The Lung Cancer App - LuCApp, Standard care
- Keywords
- Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Lung Cancer App - LuCAppOther
The Intervention Arm receiving LuCApp (The Lung Cancer App) in addition to standard care
Standard careOther
The Standard-of-Care patients receiving following the same schedule identified for LuCApp patients with paper questionnaires during clinic visits, or at home (having received paper questionnaires during the previous visit) or via telephonic interviews with the research team.
| Study group | Role | What they receive |
|---|---|---|
| LuCApp + Standard Care | Experimental | LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals.
LuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met. Receives: Other: The Lung Cancer App - LuCApp |
| Standard Care | Active comparator | Usual care will consist of standard procedures currently available at participating centers for monitoring and documenting symptoms. These therapeutical procedures are based on the guidelines developed by the National Comprehensive Cancer Network (NCCN) and the Associazione Italiana di Oncologia Medica (AIOM). Symptoms for control arm patients will be discussed and registered during scheduled clinical visits with the oncologists. Standard-of-care patients will fill out their PROMs following the same schedule identified for LuCApp patients with paper questionnaires during clinic visits, or at home (having received paper questionnaires during the previous visit) or via telephonic interviews with the research team. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in the score of the Trial Outcome Index (TOI) in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks.
FACT-L questionnaire contains four general and one lung cancer symptom-specific subscales. General subscales include: Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The Lung Cancer Subscale (LCS) assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath; loss of weight; tightness in chest). The TOI is derived by adding scores on the PWB and FWB subscales to the LCS. Because they contain the most relevant questions about symptoms and physical functioning, the LCS and TOI were selected as the primary focus of this analysis.
Measured: 12 weeks
Secondary outcomes (7)
Eq-5D-5L
EQ-5D-5L is a generic preference-based measure of health status, which is the most commonly used tool used to derive utility values that can be utilised within an economic evaluation model.
Measured: The questionnaire will be administered at baseline, every 3 ± 1 weeks up to 24 weeks from date of randomization
HADS
HADS is a self-assessment scale developed to detect states of depression, anxiety and emotional distress amongst patients treated for a variety of problems in the setting of out-patient clinics.
Measured: The questionnaire will be administered at baseline, at 12 weeks, and at 24 weeks.
SCNS-SF34
The supportive care needs survey, short form (SCNS-SF34) is a needs assessment questionnaire in cancer supportive care measuring the gap between patients' experience and their expectations.
Measured: 24 weeks
ZBI
The Zarit Burden Interview (ZBI) is a 22-item self-administered scale measuring caregiver burden in health, psychological well-being, finances, social life, and relationship with patient.
Measured: 24 weeks
Usability of LuCApp
To test usability of the App, a modified computer system usability questionnaire (CSUQ) will be administered to both patients and clinicians using LuCApp.
Measured: 24 weeks
Satisfaction of LuCApp
To test user satisfaction with the App, a modified computer system usability questionnaire (CSUQ) will be administered to both patients and clinicians using LuCApp.
Measured: 24 weeks
Resource use
Resource use will be captured through patients' reports of symptoms and clinicians actions in response to those symptoms (e.g. prescriptions, hospitalisations, change in therapy).
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start15 May 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consenting patients will be assigned in a 1:1 randomized way to receiving either standard care or LuCApp in addition to standard care. During the treatment period, LuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bocconi University
- Sponsor type
- University, hospital or other
- Collaborators
- AdvicePharma srl
- Responsible party
- Sponsor
- Investigators
- Paolo PP Pedrazzoli, MD, Principal investigator, Fondazione IRCCS Policlinico S. Matteo - Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512015
- Sponsor's protocol ID
- 200
- Acronym
- LuCApp
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2018
- Last updated
- 30 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deliberation on modality of IPD sharing to other researchers have not been made yet.
Publications
Pongiglione B, Cucciniello M, Petracca F, Ciani O, Novello S, Migliorino M, Pedrazzoli P, Agustoni F, Lo Russo G, Tarricone R, Capelletto E. A mobile supportive care app for patients with metastatic lung cancer: the Lung Cancer App (LuCApp) randomized controlled trial. Support Care Cancer. 2025 Jun 30;33(7):641. doi: 10.1007/s00520-025-09682-5.
PubMed 40586961Ciani O, Cucciniello M, Petracca F, Apolone G, Merlini G, Novello S, Pedrazzoli P, Zilembo N, Broglia C, Capelletto E, Garassino M, Nicod E, Tarricone R. Lung Cancer App (LuCApp) study protocol: a randomised controlled trial to evaluate a mobile supportive care app for patients with metastatic lung cancer. BMJ Open. 2019 Feb 15;9(2):e025483. doi: 10.1136/bmjopen-2018-025483.
PubMed 30772862
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Supportive Care App for Patients With Metastatic Lung Cancer: a Pilot Randomized Controlled Trial - The Lung Cancer App (LuCApp) Study
- ClinicalTrials.gov ID
- NCT03512015
- Acronym / sponsor ID
- LuCApp / 200
- Keywords
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bocconi UniversityUniversity, hospital or other
- Collaborators
- AdvicePharma srl
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 30 Apr 2018 (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.
Self-management interventions can help patients and their families care for themselves along the cancer care continuum. This scenario has witnessed the rapid and ongoing growth in mobile technologies, including mobile health (mHealth). LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals. This is a 24-week, two-arm, non-blinded multicenter feasibility parallel randomized controlled trial aimed to evaluate the usability and effectiveness of LuCApp vs standard care to improve self-management of symptoms and health related quality of life in lung cancer patients.
Detailed description
Background: Self-management interventions can help patients and their families care for themselves along the cancer care continuum. This scenario has witnessed the rapid and ongoing growth in mobile technologies, including mobile health (mHealth). LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals.
Objectives: To evaluate the usability and effectiveness of LuCApp vs standard care to improve self-management of symptoms and health related quality of life in lung cancer patients.
Design: This is a 24-week, two-arm, non-blinded multicenter feasibility parallel randomized controlled trial.
Patient population: Adults of both sexes diagnosed with small or non-small cell lung cancer, eligible for pharmaceutical treatments with good performance status and life expectancy of ≥6 months or more, fluently speaking Italian and able to use a smartphone will be eligible for recruitment. Participants will remain on study until discontinuation of cancer treatment, voluntary withdrawal, study termination or death.
Intervention and comparator: Consenting patients will be assigned in a 1:1 randomized way to receiving either standard care or LuCApp in addition to standard care. During the treatment period, LuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met.
Outcomes: The primary outcome is the change in the score of the Trial Outcome Index (TOI) in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks. A battery of patient-reported outcomes measures will also be assessed: the Lung Cancer Subscale, the EuroQoL 5D questionnaire, the Hospital Anxiety and Depression Scale, the Supportive Care Needs Survey Short Form, the app usability questionnaire and resource use. The Zarit Burden interview will be assessed with the main caregiver.
Conclusions: The electronic and mobile health revolution holds great potentials for improving symptom management strategies in chronic conditions, hence the evaluation of such interventions becomes important in order to bring to patients and to healthcare systems effective and cost-effective solutions. This pilot trial was designed with a pragmatic attitude to test the feasibility of LuCApp, as a technology to improve self-reporting and self-management of symptoms in patients with lung cancer, on health related quality of life and usability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Consenting patients will be assigned in a 1:1 randomized way to receiving either standard care or LuCApp in addition to standard care. During the treatment period, LuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met.
| Arm | Type | Receives |
|---|---|---|
| LuCApp + Standard Care | Experimental | Other: The Lung Cancer App - LuCAppLuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals. LuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met. |
| Standard Care | Active comparator | Other: Standard careUsual care will consist of standard procedures currently available at participating centers for monitoring and documenting symptoms. These therapeutical procedures are based on the guidelines developed by the National Comprehensive Cancer Network (NCCN) and the Associazione Italiana di Oncologia Medica (AIOM). Symptoms for control arm patients will be discussed and registered during scheduled clinical visits with the oncologists. Standard-of-care patients will fill out their PROMs following the same schedule identified for LuCApp patients with paper questionnaires during clinic visits, or at home (having received paper questionnaires during the previous visit) or via telephonic interviews with the research team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- over 18 years of age individuals of both sexes;
- diagnosed with small or non-small cell lung cancer;
- patients eligible for chemotherapy, immunotherapy or biological therapy;
- patients diagnosed with non-resectable tumor and eligible for neoadjuvant therapies;
- life expectancy of six months or more;
Key exclusion criteria (5 listed)
- individuals unable to provide written informed consent;
- individuals unable to see the App and all other materials (i.e. are blind);
- patients receiving or that plan to receive radiotherapy or surgical resection;
- patients already included or about to join other clinical trials;
- patients already using other smartphone applications to self-manage cancer symptoms.
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 |
|---|---|---|
| The Lung Cancer App - LuCAppThe Intervention Arm receiving LuCApp (The Lung Cancer App) in addition to standard care | Other | LuCApp + Standard Care |
| Standard careThe Standard-of-Care patients receiving following the same schedule identified for LuCApp patients with paper questionnaires during clinic visits, or at home (having received paper questionnaires during the previous visit) or via telephonic interviews with the research team. | Other | Standard Care |
Primary outcome
The primary outcome is the change in the score of the Trial Outcome Index (TOI) in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks.
Time frame: 12 weeks
FACT-L questionnaire contains four general and one lung cancer symptom-specific subscales. General subscales include: Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The Lung Cancer Subscale (LCS) assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath; loss of weight; tightness in chest). The TOI is derived by adding scores on the PWB and FWB subscales to the LCS. Because they contain the most relevant questions about symptoms and physical functioning, the LCS and TOI were selected as the primary focus of this analysis.
7 secondary outcomes
Eq-5D-5L
Time frame: The questionnaire will be administered at baseline, every 3 ± 1 weeks up to 24 weeks from date of randomization
HADS
Time frame: The questionnaire will be administered at baseline, at 12 weeks, and at 24 weeks.
SCNS-SF34
Time frame: 24 weeks
ZBI
Time frame: 24 weeks
Usability of LuCApp
Time frame: 24 weeks
Satisfaction of LuCApp
Time frame: 24 weeks
Resource use
Time frame: 0-24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Derived from this study: PubMed 40586961Pongiglione B, Cucciniello M, Petracca F, Ciani O, Novello S, Migliorino M, Pedrazzoli P, Agustoni F, Lo Russo G, Tarricone R, Capelletto E. A mobile supportive care app for patients with metastatic lung cancer: the Lung Cancer App (LuCApp) randomized controlled trial. Support Care Cancer. 2025 Jun 30;33(7):641. doi: 10.1007/s00520-025-09682-5.
- Derived from this study: PubMed 30772862Ciani O, Cucciniello M, Petracca F, Apolone G, Merlini G, Novello S, Pedrazzoli P, Zilembo N, Broglia C, Capelletto E, Garassino M, Nicod E, Tarricone R. Lung Cancer App (LuCApp) study protocol: a randomised controlled trial to evaluate a mobile supportive care app for patients with metastatic lung cancer. BMJ Open. 2019 Feb 15;9(2):e025483. doi: 10.1136/bmjopen-2018-025483.
- mhealth for Cancer Supportive CareLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Deliberation on modality of IPD sharing to other researchers have not been made yet.
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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.
Paolo PP Pedrazzoli, MD principal investigator
Fondazione IRCCS Policlinico S. Matteo - Pavia
Questions about this trial
What is this clinical trial studying?
A study testing The Lung Cancer App - LuCApp in people with Nonsmall Cell Lung Cancer and Small Cell Lung Carcinoma, run by Bocconi University.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo PP Pedrazzoli, MD (0382501659 ext. +39, p.pedrazzoli@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the change in the score of the Trial Outcome Index (TOI) in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512015, which also lists 2 linked publications.
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 30 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.