Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Lung Cancer, Quality of life, Lung Neoplasms, Digital Health App, THRIVE Digital Health App

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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).

You CAN'T join if...

  • 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.

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90024 United States
  • Veteran Affairs Greater Los Angeles Health Care not yet accepting patients
    Los Angeles California 90073 United States
  • Massachusetts General Hospital accepting new patients
    Boston Massachusetts 02114 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts General Hospital
ID
NCT06427954
Study Type
Interventional
Participants
Expecting 250 study participants
Last Updated