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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE Digital Health App | Active Comparator | 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. |
|
| Usual Care | No Intervention | Patients assigned to the usual care group will not receive the digital app but rather standard oncology care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health App | Behavioral | access to a digital health app |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | Quality of Life (higher scores indicate better quality of life) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MD Anderson Symptom Inventory (MDASI) | Physical Symptoms (higher scores indicate worse symptoms) | 12 weeks |
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and Depression Symptoms (higher scores indicate worse symptoms) |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Cope (Modified) | Coping (higher scores indicate greater use of coping strategy) | 12 weeks |
| Cancer Self-Efficacy Scale | Self-efficacy (higher scores indicate greater self-efficacy) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Temel | Contact | 6177244000 | jtemel@partners.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Recruiting | Los Angeles | California | 90024 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 12 weeks |
| 12 weeks |
| FACT-L | Quality of Life (higher scores indicate better quality of life) | Over 24 weeks |
| MDASI | Physical Symptoms (higher scores indicate worse symptoms) | Over 24 weeks |
| HADS | Anxiety and Depression Symptoms (higher scores indicate worse symptoms) | Over 24 weeks |
| Veteran Affairs Greater Los Angeles Health Care | Not yet recruiting | Los Angeles | California | 90073 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |