Supportive Care Mobile Application for Patients With NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer Quality of Life Coping Skills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Supportive Care Mobile Application

Intervention Type BEHAVIORAL

Tablet computer with application providing modules on skills for managing symptoms and coping.

Usual Care

Intervention Type OTHER

Standard oncology care with monitoring of supportive care services usage

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Standard oncology care with monitoring of supportive care services usage

Interventions

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Supportive Care Mobile Application

Tablet computer with application providing modules on skills for managing symptoms and coping.

Intervention Type BEHAVIORAL

Usual Care

Standard oncology care with monitoring of supportive care services usage

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No