A Mobile Supportive Care App for Patients With Metastatic Lung Cancer

NCT03512015 | Unknown

• 1 other identifier: 200
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Nonsmall Cell Lung Cancer; Small Cell Lung Carcinoma

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (7)

• Eq-5D-5L

  The questionnaire will be administered at baseline, every 3 ± 1 weeks up to 24 weeks from date of randomization

• HADS

  The questionnaire will be administered at baseline, at 12 weeks, and at 24 weeks.

• SCNS-SF34

  24 weeks

• ZBI

  24 weeks

• Usability of LuCApp

  24 weeks

Study Arms (2)

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.

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.

Other: Standard care

Interventions

The Lung Cancer App - LuCApp OTHER

The Intervention Arm receiving LuCApp (The Lung Cancer App) in addition to standard care

LuCApp + Standard Care

Standard care OTHER

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bocconi University: lead
• AdvicePharma srl: collaborator

Related Publications (2)

• 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.

  PMID: 40586961 DERIVED

• Ciani 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 DERIVED

Related Links

• mhealth for Cancer Supportive Care

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paolo PP Pedrazzoli, MD

  Fondazione IRCCS Policlinico S. Matteo - Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo PP Pedrazzoli, MD

CONTACT

0382501659; p.pedrazzoli@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 30, 2018
• Study Start: May 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: April 30, 2018

Record last verified: 2018-04