Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427954
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-17
Brief Title:
Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THRIVE
Brief 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None