Study characteristics
| . | Study 1 . | Study 2 . | Study 3 . | Study 4 . |
|---|---|---|---|---|
| ClinicalTrials.gov identifier | NA | NCT02975869 | NCT03310918 | NCT03372291 |
| Inclusion criteria (all studies: ability to provide informed consent and comprehend English) | Patient aged ≥60 y with a new diagnosis of AML receiving treatment with either intensive or nonintensive chemotherapy | Hospitalized patients with high-risk AML: newly diagnosed and age ≥60 y, or newly diagnosed with antecedent hematological disorder, or newly diagnosed with therapy-related AML, or relapsed AML, or primary refractory AML. | Patients aged ≥18 y with newly diagnosed, relapsed, or primary refractory AML receiving nonintensive chemotherapy inpatient or outpatient. | Patients aged ≥18 y with newly diagnosed AML receiving intensive induction chemotherapy requiring 4-6 wk hospitalization. |
| Intervention | Prospective longitudinal observational study | Integrated palliative and oncology care: standard of care plus collaborative involvement of palliative care clinicians | Integrated palliative and oncology care: standard of care plus collaborative involvement of palliative care clinicians | Standard of care plus psychological intervention delivered via mobile application focused on educating patients about leukemia and how to cope with its treatment |
| Control condition | NA | Standard of care | Standard of care | Standard of care |
| Randomized | NA | Yes | Yes | Yes |
| Primary outcome | FACT-Leukemia score | FACT-Leukemia score at 2 wk | Time from documentation of end-of-life care preferences to death | Feasibility based on proportion of subjects enrolled and completing the app modules |
| FACT-PWB time points | Baseline, wk 2, 4, 8, 12, and 24 | Baseline, wk 2, 4, 12, and 24 | Baseline, 1 mo, 3 mo, 6 mo | Baseline, 2 wk, 20 d, 40 d |
| Planned days of follow-up | 24 wk | Up to 192 (24 wk ± 7 d) | ∼180 (depends on visit ranges) | Up to 50 d (depends on visit ranges) |
| No. of patients contributed to analysis | 99 | 160 | 88 | 58 |
| . | Study 1 . | Study 2 . | Study 3 . | Study 4 . |
|---|---|---|---|---|
| ClinicalTrials.gov identifier | NA | NCT02975869 | NCT03310918 | NCT03372291 |
| Inclusion criteria (all studies: ability to provide informed consent and comprehend English) | Patient aged ≥60 y with a new diagnosis of AML receiving treatment with either intensive or nonintensive chemotherapy | Hospitalized patients with high-risk AML: newly diagnosed and age ≥60 y, or newly diagnosed with antecedent hematological disorder, or newly diagnosed with therapy-related AML, or relapsed AML, or primary refractory AML. | Patients aged ≥18 y with newly diagnosed, relapsed, or primary refractory AML receiving nonintensive chemotherapy inpatient or outpatient. | Patients aged ≥18 y with newly diagnosed AML receiving intensive induction chemotherapy requiring 4-6 wk hospitalization. |
| Intervention | Prospective longitudinal observational study | Integrated palliative and oncology care: standard of care plus collaborative involvement of palliative care clinicians | Integrated palliative and oncology care: standard of care plus collaborative involvement of palliative care clinicians | Standard of care plus psychological intervention delivered via mobile application focused on educating patients about leukemia and how to cope with its treatment |
| Control condition | NA | Standard of care | Standard of care | Standard of care |
| Randomized | NA | Yes | Yes | Yes |
| Primary outcome | FACT-Leukemia score | FACT-Leukemia score at 2 wk | Time from documentation of end-of-life care preferences to death | Feasibility based on proportion of subjects enrolled and completing the app modules |
| FACT-PWB time points | Baseline, wk 2, 4, 8, 12, and 24 | Baseline, wk 2, 4, 12, and 24 | Baseline, 1 mo, 3 mo, 6 mo | Baseline, 2 wk, 20 d, 40 d |
| Planned days of follow-up | 24 wk | Up to 192 (24 wk ± 7 d) | ∼180 (depends on visit ranges) | Up to 50 d (depends on visit ranges) |
| No. of patients contributed to analysis | 99 | 160 | 88 | 58 |
NA, not applicable.