Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06427954

Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer

Multi-site randomized trial of the THRIVE digital health application versus usual care to evaluate the effect of THRIVE on quality of life (QOL), physical and psychological symptoms, coping, and self-efficacy in 250 patients with newly diagnosed advanced lung cancer.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

Multi-site randomized controlled trial of the THRIVE digital health application versus usual care in 250 patients diagnosed with advanced lung cancer within the previous 12 weeks to examine the effect of the intervention on patient-reported QOL, physical symptoms, anxiety and depression symptoms, coping, and self-efficacy. Participants will be randomized in a 1:1 fashion and stratified by study site and lung cancer type to ensure a balanced representation of these factors between the two study groups. The study team will provide iPads to patients assigned to THRIVE and provide instructions on how to use the iPad and digital app. The study team will administer patient-reported outcome measures at enrollment and again at six, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of THRIVE.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (greater than or equal to 18 years)
  • Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not being treated with curative intent or extensive stage small cell lung cancer (SCLC) within the past 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours).
  • Sufficient English proficiency to utilize THRIVE in English (Note: patients can complete outcome measures in Spanish if preferred).

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.

Treatment and study plan

Digital Health App

Behavioral

access to a digital health app

Primary outcomes

  1. Functional Assessment of Cancer Therapy - Lung (FACT-L)

    Time frame: 12 weeks

    Quality of Life (higher scores indicate better quality of life)

Secondary outcomes

  1. MD Anderson Symptom Inventory (MDASI)

    Time frame: 12 weeks

    Physical Symptoms (higher scores indicate worse symptoms)

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 12 weeks

    Anxiety and Depression Symptoms (higher scores indicate worse symptoms)

Other outcomes

  1. Brief Cope (Modified)

    Time frame: 12 weeks

    Coping (higher scores indicate greater use of coping strategy)

  2. Cancer Self-Efficacy Scale

    Time frame: 12 weeks

    Self-efficacy (higher scores indicate greater self-efficacy)

  3. FACT-L

    Time frame: Over 24 weeks

    Quality of Life (higher scores indicate better quality of life)

  4. MDASI

    Time frame: Over 24 weeks

    Physical Symptoms (higher scores indicate worse symptoms)

  5. HADS

    Time frame: Over 24 weeks

    Anxiety and Depression Symptoms (higher scores indicate worse symptoms)

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Temel

CONTACT

[email protected]

6177244000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer

Acronym: THRIVE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 24, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.