Clinical trial NCT04629300: Supportive Care Mobile Application for Patients With NSCLC
Official title: Randomized Trial of a Supportive Care Mobile Application to Improve Symptoms, Coping, and Quality of Life in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Quality of Life
Coping Skills
Keywords: Non Small Cell Lung Cancer
Portable Electronic Applications
Quality of Life
Coping Skills
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2020-11-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study feasibility based on rates of participant recruitment and completion of assigned study procedures
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient-reported acceptability and usability of the mobile application intervention on the System Usability Scale
timeFrame: 12 weeks
measure: Compare patient-reported quality of life between study groups on the Functional Assessment of Cancer Therapy-Lung Scale
timeFrame: 12 weeks
measure: Compare patient-reported symptoms between study groups on the MD Anderson Symptom Inventory
timeFrame: 12 weeks
measure: Compare patient-reported psychological distress between study groups on the Hospital Anxiety and Depression Scale
timeFrame: 12 weeks
measure: Compare patient-reported coping between study groups on the Brief COPE Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Danvers
country: United States
facility: Mass General/North Shore Cancer Center
state: Massachusetts
city: Milford
country: United States
facility: Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: South Weymouth
country: United States
facility: Dana-Farber Brigham Cancer Center at South Shore
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Greer, PHD
role: PRINCIPAL_INVESTIGATOR
References: