NCT03512015

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bocconi University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonsmall Cell Lung Cancer
• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
OTHER	The Lung Cancer App - LuCApp	The Intervention Arm receiving LuCApp (The Lung Cancer App) in addition to standard care
OTHER	Standard care	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.

Timeline

• Start date: 2018-05-15
• Primary completion: 2019-12-31
• Completion: 2020-06-30
• First posted: 2018-04-30
• Last updated: 2018-04-30