Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06427954

Recruiting

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

Interventional

Phase not listed

Mass General Hospital

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.

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Treatment Category

Behavioral

Required Mutations

None

Trial Started

2024-08-06

Last Updated by Sponsor

2024-11-25

Estimated Completion

2027-09-01

Eligibility

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).

* 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.

Exclusion Criteria

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingSingle

Number to Enroll250

Arms & Interventions

Arms

Interventions

Type: Active Comparator

Description: 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.

Interventions:

Digital Health App

Outcome Measures

Primary Outcome Measures

Functional Assessment of Cancer Therapy - Lung (FACT-L)12 weeks

Quality of Life (higher scores indicate better quality of life)

Secondary Outcome Measures

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)

Brief Cope (Modified)12 weeks

Coping (higher scores indicate greater use of coping strategy)

Cancer Self-Efficacy Scale12 weeks

Self-efficacy (higher scores indicate greater self-efficacy)

FACT-LOver 24 weeks

Quality of Life (higher scores indicate better quality of life)

MDASIOver 24 weeks

Physical Symptoms (higher scores indicate worse symptoms)

HADSOver 24 weeks

Anxiety and Depression Symptoms (higher scores indicate worse symptoms)

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Trial Sites

This study has 3 trial sites

Mass General Hospital
Boston, Massachusetts, US

Recruiting

Boston, Massachusetts, 02114 US

Mass General Hospital

Recruiting

Los Angeles, California, 90024 US

University of California Los Angeles

Not yet recruiting

Los Angeles, California, 90073 US

Veteran Affairs Greater Los Angeles Health Care

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