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

July 9, 2026 updated by: Jennifer Temel, MD, Massachusetts General Hospital

Randomized Trial of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
      • Los Angeles, California, United States, 90073
        • Not yet recruiting
        • Veteran Affairs Greater Los Angeles Health Care
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Jennifer Temel, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: THRIVE Digital Health App
Patients assigned to the intervention will be provided a study-issued tablet computer from which they will access the THRIVE digital health app. Study staff will give intervention patients a comprehensive tutorial and detailed instructions regarding how to use the app. Tutorial sessions may be conducted in person during a clinic appointment, via telephone, and/or via Zoom videoconferencing. Participants will complete the intervention modules at their desired pace over approximately 10 weeks.
Behavioral: Digital Health App
access to a digital health app
No Intervention: Usual Care
Patients assigned to the usual care group will not receive the digital app but rather standard oncology care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - Lung (FACT-L)
Time Frame: 12 weeks
Quality of Life (higher scores indicate better quality of life)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MD Anderson Symptom Inventory (MDASI)
Time Frame: 12 weeks
Physical Symptoms (higher scores indicate worse symptoms)
12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12 weeks
Anxiety and Depression Symptoms (higher scores indicate worse symptoms)
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Cope (Modified)
Time Frame: 12 weeks
Coping (higher scores indicate greater use of coping strategy)
12 weeks
Cancer Self-Efficacy Scale
Time Frame: 12 weeks
Self-efficacy (higher scores indicate greater self-efficacy)
12 weeks
FACT-L
Time Frame: Over 24 weeks
Quality of Life (higher scores indicate better quality of life)
Over 24 weeks
MDASI
Time Frame: Over 24 weeks
Physical Symptoms (higher scores indicate worse symptoms)
Over 24 weeks
HADS
Time Frame: Over 24 weeks
Anxiety and Depression Symptoms (higher scores indicate worse symptoms)
Over 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-091

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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