Current goals of care and palliative care interventions for patients with hematologic malignancies
| Clinicaltrials.gov ID . | Design . | Intervention . | Patient population . | Outcome measures . |
|---|---|---|---|---|
| NCT05433090 | Single-arm pilot (n = 50) | Inpatient advance care planning intervention (adaptation of Serious Illness Care Program) | Hospitalized patients with hematologic malignancies ≥60 years old | Primary: completion of advance directives Secondary: EOL quality indicators |
| NCT05444348 | Parallel assignment (n = 920) | 60-minute consultation with focus on issues of importance to patient and caregiver (“Advance consultation concerning your life and treatment”) | Patients with high-risk MDS, high-risk MDS/MPN, AML receiving noncurative treatment or relapsed, lymphoma age ≥80 years, or relapsed/refractory or on palliative therapy, or relapsed/refractory multiple myeloma | Primary: (1) use of chemo at EOL; (2) longitudinal change in patient and caregiver anxiety Secondary: include additional EOL quality indicators, QOL, psychological outcomes, prognostic understanding, and caregiver outcomes |
| NCT05335369 | Parallel assignment (n = 100) | Patient-centered communication tool that (1) conducts assessments of fitness, (2) elicits patient values, and (3) elicits preferences for prognostic information and assesses prognostic awareness | Patients with newly diagnosed AML ≥60 years | Primary: patient-reported shared decision-making Secondary: patient-centered communication in cancer care |
| NCT05875805 | Parallel assignment (n = 64) | Telehealth Serious Illness Care Program | Patients with myeloid malignancy ≥60 years | Primary: healthcare communication Secondary: distress, anxiety, completion of advance directives |
| NCT04482894 | Parallel assignment (n = 105) | Regular visits with palliative care specialist (twice weekly while in hospital, every other week out of hospital) | Diagnosis of AML, ALL, high-risk MDS, high-risk CMML in (1) patients ≥65 years with new diagnosis and (2) patients ≥18 years with relapsed or refractory disease | Primary: place of death Secondary: measures of quality EOL care and overall survival |
| NCT03310918 | Parallel assignment (n = 320) | Collaborative palliative and oncology care (palliative care visits at least twice weekly while in hospital; in outpatient setting, once weekly for first month then at least twice monthly) | Diagnosis of AML, including newly diagnosed, relapsed, or primary refractory, on non-intensive therapy | Primary: time from documentation of EOL care preferences to death Secondary: measures of quality EOL care, psychological outcomes, EOL care preference discussion and documentation rate |
| NCT05237258 | Parallel assignment, noninferiority trial (n = 2300) | Specialty palliative care vs primary palliative care during all hospitalizations for AML | Diagnosis of high-risk AML (≥60 years or antecedent hematologic disorder, therapy-related AML, or relapsed or refractory AML), receiving cancer-directed treatment | Primary: QOL Secondary: additional psychological outcomes, quality EOL care measures, caregiver outcomes, EOL communication |
| NCT04885127 | Single arm (n = 40) | Virtually mediated supportive care model using palliative care virtual visits and digital symptom monitoring | Diagnosis of AML on low-intensity induction chemo with life expectancy of 6 months | Primary: feasibility Secondary: symptom burden, anxiety, depression, satisfaction |
| NCT05646576 | Parallel assignment (n = 90) | Visits with palliative care (within 1 week of T-cell collection and within 3 days of hospital admission for cellular therapy, then twice weekly during hospitalizations) | Diagnosis of hematologic malignancy, receiving autologous adoptive cellular therapy | Primary: feasibility Secondary: acceptability, QOL, psychological outcomes, prognostic understanding, EOL communication |
| NCT05190653 | Parallel assignment (n = 152) | Visits with palliative care (pre-transplant/CAR T-cell therapy, then 1-2 times weekly until 3 months post-therapy) | Diagnosis of hematologic malignancy with scheduled HSCT or CAR T-cell therapy | Primary: patient QOL Secondary: symptom burden, prognostic understanding, caregiver QOL |
| Clinicaltrials.gov ID . | Design . | Intervention . | Patient population . | Outcome measures . |
|---|---|---|---|---|
| NCT05433090 | Single-arm pilot (n = 50) | Inpatient advance care planning intervention (adaptation of Serious Illness Care Program) | Hospitalized patients with hematologic malignancies ≥60 years old | Primary: completion of advance directives Secondary: EOL quality indicators |
| NCT05444348 | Parallel assignment (n = 920) | 60-minute consultation with focus on issues of importance to patient and caregiver (“Advance consultation concerning your life and treatment”) | Patients with high-risk MDS, high-risk MDS/MPN, AML receiving noncurative treatment or relapsed, lymphoma age ≥80 years, or relapsed/refractory or on palliative therapy, or relapsed/refractory multiple myeloma | Primary: (1) use of chemo at EOL; (2) longitudinal change in patient and caregiver anxiety Secondary: include additional EOL quality indicators, QOL, psychological outcomes, prognostic understanding, and caregiver outcomes |
| NCT05335369 | Parallel assignment (n = 100) | Patient-centered communication tool that (1) conducts assessments of fitness, (2) elicits patient values, and (3) elicits preferences for prognostic information and assesses prognostic awareness | Patients with newly diagnosed AML ≥60 years | Primary: patient-reported shared decision-making Secondary: patient-centered communication in cancer care |
| NCT05875805 | Parallel assignment (n = 64) | Telehealth Serious Illness Care Program | Patients with myeloid malignancy ≥60 years | Primary: healthcare communication Secondary: distress, anxiety, completion of advance directives |
| NCT04482894 | Parallel assignment (n = 105) | Regular visits with palliative care specialist (twice weekly while in hospital, every other week out of hospital) | Diagnosis of AML, ALL, high-risk MDS, high-risk CMML in (1) patients ≥65 years with new diagnosis and (2) patients ≥18 years with relapsed or refractory disease | Primary: place of death Secondary: measures of quality EOL care and overall survival |
| NCT03310918 | Parallel assignment (n = 320) | Collaborative palliative and oncology care (palliative care visits at least twice weekly while in hospital; in outpatient setting, once weekly for first month then at least twice monthly) | Diagnosis of AML, including newly diagnosed, relapsed, or primary refractory, on non-intensive therapy | Primary: time from documentation of EOL care preferences to death Secondary: measures of quality EOL care, psychological outcomes, EOL care preference discussion and documentation rate |
| NCT05237258 | Parallel assignment, noninferiority trial (n = 2300) | Specialty palliative care vs primary palliative care during all hospitalizations for AML | Diagnosis of high-risk AML (≥60 years or antecedent hematologic disorder, therapy-related AML, or relapsed or refractory AML), receiving cancer-directed treatment | Primary: QOL Secondary: additional psychological outcomes, quality EOL care measures, caregiver outcomes, EOL communication |
| NCT04885127 | Single arm (n = 40) | Virtually mediated supportive care model using palliative care virtual visits and digital symptom monitoring | Diagnosis of AML on low-intensity induction chemo with life expectancy of 6 months | Primary: feasibility Secondary: symptom burden, anxiety, depression, satisfaction |
| NCT05646576 | Parallel assignment (n = 90) | Visits with palliative care (within 1 week of T-cell collection and within 3 days of hospital admission for cellular therapy, then twice weekly during hospitalizations) | Diagnosis of hematologic malignancy, receiving autologous adoptive cellular therapy | Primary: feasibility Secondary: acceptability, QOL, psychological outcomes, prognostic understanding, EOL communication |
| NCT05190653 | Parallel assignment (n = 152) | Visits with palliative care (pre-transplant/CAR T-cell therapy, then 1-2 times weekly until 3 months post-therapy) | Diagnosis of hematologic malignancy with scheduled HSCT or CAR T-cell therapy | Primary: patient QOL Secondary: symptom burden, prognostic understanding, caregiver QOL |
ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; CAR, chimeric antigen receptor; CMML, chronic myelomonocytic leukemia; EOL, end-of-life; HSCT, hematopoietic stem cell transplantation; MDS, myelodysplastic syndromes; MPN, myeloproliferative neoplasms; QOL, quality of life.