Clinical trial NCT06427954: Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
Official title: Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Quality of life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-05-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Lung (FACT-L)
timeFrame: 12 weeks
Secondary outcomes:
measure: MD Anderson Symptom Inventory (MDASI)
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
Other outcomes:
measure: Brief Cope (Modified)
timeFrame: 12 weeks
measure: Cancer Self-Efficacy Scale
timeFrame: 12 weeks
measure: FACT-L
timeFrame: Over 24 weeks
measure: MDASI
timeFrame: Over 24 weeks
measure: HADS
timeFrame: Over 24 weeks
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: Veteran Affairs Greater Los Angeles Health Care
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: