Clinical trial NCT03512015: A Mobile Supportive Care App for Patients With Metastatic Lung Cancer
Official title: A Mobile Supportive Care App for Patients With Metastatic Lung Cancer: a Pilot Randomized Controlled Trial - The Lung Cancer App (LuCApp) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonsmall Cell Lung Cancer
Small Cell Lung Carcinoma
Keywords: Lung Cancer
Lead sponsor: Bocconi University
Sponsor class: OTHER
Collaborators: name: AdvicePharma srl
First posted: 2018-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Eq-5D-5L
timeFrame: The questionnaire will be administered at baseline, every 3 ± 1 weeks up to 24 weeks from date of randomization
measure: HADS
timeFrame: The questionnaire will be administered at baseline, at 12 weeks, and at 24 weeks.
measure: SCNS-SF34
timeFrame: 24 weeks
measure: ZBI
timeFrame: 24 weeks
measure: Usability of LuCApp
timeFrame: 24 weeks
measure: Satisfaction of LuCApp
timeFrame: 24 weeks
measure: Resource use
timeFrame: 0-24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione IRCCS Policlinico S. Matteo - Pavia
name: Paolo PP Pedrazzoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.