Clinical trial · Interventional

A Mobile Supportive Care App for Patients With Metastatic Lung Cancer

A Mobile Supportive Care App for Patients With Metastatic Lung Cancer: a Pilot Randomized Controlled Trial - The Lung Cancer App (LuCApp) Study

NCT03512015CI-TRIAL-00032720LuCAppunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Nonsmall Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90
Small Cell Lung Carcinoma	Lung Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Standard care	Other	—	UNRESOLVED
The Lung Cancer App - LuCApp	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
LuCApp + Standard Care
description
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.
interventionNames
1. Other: The Lung Cancer App - LuCApp
type
ACTIVE_COMPARATOR
label
Standard Care
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 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;
* 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.

Exclusion Criteria:

* 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.

References

Publications (2)

DERIVEDPongiglione 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. PMID 40586961
DERIVEDCiani 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. PMID 30772862