A Mobile Supportive Care App for Patients With Metastatic Lung Cancer (LuCApp)

April 18, 2018 updated by: Bocconi University

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LuCApp + Standard Care

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.

The Intervention Arm receiving LuCApp (The Lung Cancer App) in addition to standard care
Active Comparator: Standard Care
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eq-5D-5L
Time Frame: The questionnaire will be administered at baseline, every 3 ± 1 weeks up to 24 weeks from date of randomization
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.
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.
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.
The questionnaire will be administered at baseline, at 12 weeks, and at 24 weeks.
SCNS-SF34
Time Frame: 24 weeks
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.
24 weeks
ZBI
Time Frame: 24 weeks
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.
24 weeks
Usability of LuCApp
Time Frame: 24 weeks
To test usability of the App, a modified computer system usability questionnaire (CSUQ) will be administered to both patients and clinicians using LuCApp.
24 weeks
Satisfaction of LuCApp
Time Frame: 24 weeks
To test user satisfaction with the App, a modified computer system usability questionnaire (CSUQ) will be administered to both patients and clinicians using LuCApp.
24 weeks
Resource use
Time Frame: 0-24 weeks
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).
0-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Paolo PP Pedrazzoli, MD, Fondazione IRCCS Policlinico S. Matteo - Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 30, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Deliberation on modality of IPD sharing to other researchers have not been made yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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