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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Digital Health App

• Registration Number: NCT06427954
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-24
• Study Start: 2024-08-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2027-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THRIVE Digital Health App	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.

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy - Lung (FACT-L)	12 weeks	Quality of Life (higher scores indicate better quality of life)

Secondary Outcome Measures

Name	Time	Method
MD Anderson Symptom Inventory (MDASI)	12 weeks	Physical Symptoms (higher scores indicate worse symptoms)
Hospital Anxiety and Depression Scale (HADS)	12 weeks	Anxiety and Depression Symptoms (higher scores indicate worse symptoms)

Trial Locations

Locations (3)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Veteran Affairs Greater Los Angeles Health Care; 🇺🇸 Los Angeles, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States