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Trial Title:
Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
NCT ID:
NCT06427954
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Investigator)
Intervention:
Intervention type:
Behavioral
Intervention name:
Digital Health App
Description:
access to a digital health app
Arm group label:
THRIVE Digital Health App
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California Los Angeles
Address:
City:
Los Angeles
Zip:
90024
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Anne Walling
Email:
AWalling@mednet.ucla.edu
Facility:
Name:
Veteran Affairs Greater Los Angeles Health Care
Address:
City:
Los Angeles
Zip:
90073
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Anne Walling
Email:
anne.walling@va.gov
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Temel, MD
Phone:
617-724-4000
Email:
JTEMEL@mgh.harvard.edu
Investigator:
Last name:
Jennifer Temel, MD
Email:
Principal Investigator
Start date:
August 6, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06427954
