Supportive Care Mobile Application for Patients With NSCLC

Mass General Brigham

Status: Completed

Conditions: Quality of Life; Coping Skills; Non Small Cell Lung Cancer

Treatments: Behavioral: Supportive Care Mobile Application; Other: Usual Care

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04629300

20-398

Details and patient eligibility

About

This research study is looking at the role of a supportive care mobile app in improving symptoms, coping skills, and quality of life in patients with non-small cell lung cancer.

Full description

This research study is a Feasibility Study, which is the first-time investigators are examining this supportive care mobile app intervention. The goal of this research study is to refine and examine the feasibility and benefits of a supportive care mobile app to improve symptoms, coping skills, and quality of life in patients with non-small cell lung cancer. Many people diagnosed with lung cancer experience challenging symptoms and increased stress. To help address these concerns, this study is exploring how a mobile application (app) intervention, designed specifically for people with lung cancer, can expand the availability of much needed supportive care services.

The research study procedures include:

• A supportive care mobile app consisting of six intervention modules that focus on components of wellbeing, such as physical, social, functional, and emotional wellbeing
• Questionnaires asking about demographic information (e.g., gender, ethnicity, income) and participants' experience with cancer (e.g., quality of life, symptoms)
• Data collection from participants medical records

After completing a baseline study questionnaire, participants will be randomized into two (2) study groups:

• Usual Care Group: Participants will receive standard oncology care and attend their regular clinic visits. Study staff will monitor participant use of supportive care services.
• Intervention Group: Participants will be provided with a study-issued tablet computer to access the mobile app and receive tutorial and instructions for how to use the app.

Participants will be in this research study for 12-14 weeks.

It is expected that about 120 people will take part in this research study.

The sponsors of this study are the National Comprehensive Cancer Network (NCCN) and AstraZeneca Pharmaceuticals. NCCN is a non-profit alliance of leading cancer centers across the United States, and AstraZeneca Pharmaceuticals is a global bio-pharmaceutical company. These two sponsors are together providing funding and oversight for the conduct of this research study.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Diagnosed with unresectable Stage III or IV NSCLC in the past twelve weeks and receiving care with palliative intent (per clinician documentation in the electronic health record)
• Eastern Cooperative Oncology Group Performance Status = 0-3
• Plan to receive oncology care at one of the participating study sites
• Ability to read and respond to questions in English

Exclusion criteria

• Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Supportive Care Mobile Application

Experimental group

Description:

Complete study questionnaires at two time points: * upon enrollment at baseline prior to randomization * approximately 12 weeks after the baseline assessment time point. Participants will be provided with a study-issued tablet computer to access mobile app and receive a comprehensive tutorial and detailed instructions on how to use the app. Participants will have approximately 10 weeks to complete the intervention modules at self initiated pace. The app will provide prompts as reminders to complete the modules. Participants will receive standard oncology care. Study staff will monitor participant use of supportive care services, such as social work, psychology, psychiatry, and palliative care.

Treatment:

Other: Usual Care

Behavioral: Supportive Care Mobile Application

Usual Care

Active Comparator group

Description:

Complete study questionnaires at two time points: * upon enrollment at baseline prior to randomization * approximately 12 weeks after the baseline assessment time point. Participants will receive standard oncology care. Study staff will monitor participant use of supportive care services, such as social work, psychology, psychiatry, and palliative care.

Treatment:

Other: Usual Care