Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age >18 years - Diagnosed with unresectable Stage III or IV NSCLC in the past eight weeks and receiving first-line therapy 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Supportive Care Mobile Application
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.
  • Behavioral: Supportive Care Mobile Application
    Tablet computer with application providing modules on skills for managing symptoms and coping.
  • Other: Usual Care
    Standard oncology care with monitoring of supportive care services usage
Active Comparator
Usual Care
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.
  • Other: Usual Care
    Standard oncology care with monitoring of supportive care services usage

Recruiting Locations

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Joseph Greer, PHD
617-643-2143
jgreer2@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Joseph Greer, PHD
(617) 643-2143
jgreer2@mgh.harvard.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.