Description of RCTs of outpatient specialty palliative care for patients with advanced cancer identified in systematic review
| Evidencea . | Study . | Design . | Intervention . | Control . | Demographics . | Cancer site . | QOL measures . | Survival . |
|---|---|---|---|---|---|---|---|---|
| High-quality evidence | Temel (2017) USA (MA) N = 350 | RCT | Outpatient consultation team n = 175 | Usual care n = 175 | Age: M(SD) = 65 (11) Gender: 46% female Race: 92% white | 55% lung, 45% GI | FACT-G, PHQ-9, HADS-D, HADS-A | 3 and 6 months |
| Bakitas (2015) USA (NH, VT) N = 207 | Fast-track RCT | Outpatient consultation and manualized telehealth support, symptom management, care coordination, and life review n = 104 | Usual care for 3 months, then delayed access to the intervention n = 103 | Age: M(SD) = 64 (10) Gender: 47% female Race: 97% white | 43% lung, 24% GI, 11% breast, 22% other | FACIT-Palliative, QUAL-E, CES-D | 3, 6, 9, 12 month, and Kaplan–Meier | |
| Zimmermann (2014) Canada N = 461 | 24-Cluster RCT | Outpatient consultation team and access to on-call, inpatient, and home services n = 228 | Usual care n = 233 | Age: M(SD) = 61 (12) Gender: 57% female Race: Not reported | 30% GI, 22% lung, 17% GU, 16% breast, 15% gynecologic | ESAS, QUAL-E, FACIT-Spiritual | 3 months | |
| Temel (2010) USA (MA) N = 151 | RCT | Outpatient consultation team n = 77 | Usual care n = 74 | Age: M(SD) = 65 (10) Gender: 52% female Race: 97% white | 100% lung | FACT-L, PHQ-9, HADS-D, HADS-A | 3, 6, 9, 12, 15, 18, 21, and 24 months, and Kaplan–Meier | |
| Bakitas (2009) USA (NH, VT) N = 322 | RCT | Manualized telehealth support, symptom management, care coordination, and shared medical appointments n = 161 | Usual care n = 161 | Age: M(SD) = 65 (11) Gender: 42% female Race: 99% white | 41% GI, 36% lung, 12% GU, 10% breast | ESAS, FACIT-Palliative, CES-D | 3, 6, 9, 12, 15, 18, 21, and 24 months, and Kaplan–Meier | |
| Preliminary evidence | McCorkle (2015) USA (CT) N = 146 | 4-Cluster RCT | Multidisciplinary outpatient consultation team n = 66 | Usual care n = 80 | Age: M = 60 Gender: 56% female Race: 85% white | 36% GI, 20% gynecologic, 18% head/neck, 25% lung | FACT-G, ESDS, HADS-A, PHQ-9, HDS, SDS | 3 months |
| Higginson (2014) UK (England) N = 21 (105)b | Fast-track RCT | Multidisciplinary outpatient consultation team and home assessment of breathlessness n = 11 (53)b | Usual care for 6 weeks, then delayed access to the intervention n = 10 (52)b | Age: M(SD) = 67 (10) Gender: 42% female Race: Not reported | 62% lung, 14% hematologic, 10% GU, 14% other | None reported | 3 and 6 months | |
| Jordhøy (2001) Norway N = 434 | 6-Cluster RCT | Multidisciplinary outpatient consultation team n = 235 | Usual care n = 199 | Age: Median = 70 Gender: 47% female Race: Not reported | 42% GI, 16% GU, 15% breast/gyn, 12% lung, 15% other | EORTC QLQ-C30 | 3, 6, and 24 months | |
| Excluded from meta-analyses | Rabow (2004) USA (CA) N = 30 (90)b | 2-Cluster RCT | Multidisciplinary outpatient consultation team n = 13 (50)b | Usual care n = 17 (40)b | Age: M(SD) = 69 (13) Gender: 64% female Race: 53% white | Not reported | None reported | None reported |
| Evidencea . | Study . | Design . | Intervention . | Control . | Demographics . | Cancer site . | QOL measures . | Survival . |
|---|---|---|---|---|---|---|---|---|
| High-quality evidence | Temel (2017) USA (MA) N = 350 | RCT | Outpatient consultation team n = 175 | Usual care n = 175 | Age: M(SD) = 65 (11) Gender: 46% female Race: 92% white | 55% lung, 45% GI | FACT-G, PHQ-9, HADS-D, HADS-A | 3 and 6 months |
| Bakitas (2015) USA (NH, VT) N = 207 | Fast-track RCT | Outpatient consultation and manualized telehealth support, symptom management, care coordination, and life review n = 104 | Usual care for 3 months, then delayed access to the intervention n = 103 | Age: M(SD) = 64 (10) Gender: 47% female Race: 97% white | 43% lung, 24% GI, 11% breast, 22% other | FACIT-Palliative, QUAL-E, CES-D | 3, 6, 9, 12 month, and Kaplan–Meier | |
| Zimmermann (2014) Canada N = 461 | 24-Cluster RCT | Outpatient consultation team and access to on-call, inpatient, and home services n = 228 | Usual care n = 233 | Age: M(SD) = 61 (12) Gender: 57% female Race: Not reported | 30% GI, 22% lung, 17% GU, 16% breast, 15% gynecologic | ESAS, QUAL-E, FACIT-Spiritual | 3 months | |
| Temel (2010) USA (MA) N = 151 | RCT | Outpatient consultation team n = 77 | Usual care n = 74 | Age: M(SD) = 65 (10) Gender: 52% female Race: 97% white | 100% lung | FACT-L, PHQ-9, HADS-D, HADS-A | 3, 6, 9, 12, 15, 18, 21, and 24 months, and Kaplan–Meier | |
| Bakitas (2009) USA (NH, VT) N = 322 | RCT | Manualized telehealth support, symptom management, care coordination, and shared medical appointments n = 161 | Usual care n = 161 | Age: M(SD) = 65 (11) Gender: 42% female Race: 99% white | 41% GI, 36% lung, 12% GU, 10% breast | ESAS, FACIT-Palliative, CES-D | 3, 6, 9, 12, 15, 18, 21, and 24 months, and Kaplan–Meier | |
| Preliminary evidence | McCorkle (2015) USA (CT) N = 146 | 4-Cluster RCT | Multidisciplinary outpatient consultation team n = 66 | Usual care n = 80 | Age: M = 60 Gender: 56% female Race: 85% white | 36% GI, 20% gynecologic, 18% head/neck, 25% lung | FACT-G, ESDS, HADS-A, PHQ-9, HDS, SDS | 3 months |
| Higginson (2014) UK (England) N = 21 (105)b | Fast-track RCT | Multidisciplinary outpatient consultation team and home assessment of breathlessness n = 11 (53)b | Usual care for 6 weeks, then delayed access to the intervention n = 10 (52)b | Age: M(SD) = 67 (10) Gender: 42% female Race: Not reported | 62% lung, 14% hematologic, 10% GU, 14% other | None reported | 3 and 6 months | |
| Jordhøy (2001) Norway N = 434 | 6-Cluster RCT | Multidisciplinary outpatient consultation team n = 235 | Usual care n = 199 | Age: Median = 70 Gender: 47% female Race: Not reported | 42% GI, 16% GU, 15% breast/gyn, 12% lung, 15% other | EORTC QLQ-C30 | 3, 6, and 24 months | |
| Excluded from meta-analyses | Rabow (2004) USA (CA) N = 30 (90)b | 2-Cluster RCT | Multidisciplinary outpatient consultation team n = 13 (50)b | Usual care n = 17 (40)b | Age: M(SD) = 69 (13) Gender: 64% female Race: 53% white | Not reported | None reported | None reported |
CES-D Center for Epidemiological Studies Depression Scale; EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire; ESAS Edmonton Symptom Assessment Scale; ESDS Enforced Social Dependency Scale; FACIT Functional Assessment of Chronic Illness Therapy; FACT Functional Assessment of Cancer Therapy (G = General, L = Lung); GI gastrointestinal; GU genitourinary; HADS Hospital Anxiety and Depression Scale; HD Health Distress Scale; PHQ-9 Patient Health Questionnaire; QOL Quality of Life; QUAL-E Quality of Life at End of Life scale; SDS Symptom Distress Scale.
aHigh-quality studies had to have randomization procedures reasonable for avoiding confounding and involve ≥100 cancer patients (see Methods for details).
bParenthetical values indicate samples sizes for all study participants, including those without cancer.
Description of RCTs of outpatient specialty palliative care for patients with advanced cancer identified in systematic review
| Evidencea . | Study . | Design . | Intervention . | Control . | Demographics . | Cancer site . | QOL measures . | Survival . |
|---|---|---|---|---|---|---|---|---|
| High-quality evidence | Temel (2017) USA (MA) N = 350 | RCT | Outpatient consultation team n = 175 | Usual care n = 175 | Age: M(SD) = 65 (11) Gender: 46% female Race: 92% white | 55% lung, 45% GI | FACT-G, PHQ-9, HADS-D, HADS-A | 3 and 6 months |
| Bakitas (2015) USA (NH, VT) N = 207 | Fast-track RCT | Outpatient consultation and manualized telehealth support, symptom management, care coordination, and life review n = 104 | Usual care for 3 months, then delayed access to the intervention n = 103 | Age: M(SD) = 64 (10) Gender: 47% female Race: 97% white | 43% lung, 24% GI, 11% breast, 22% other | FACIT-Palliative, QUAL-E, CES-D | 3, 6, 9, 12 month, and Kaplan–Meier | |
| Zimmermann (2014) Canada N = 461 | 24-Cluster RCT | Outpatient consultation team and access to on-call, inpatient, and home services n = 228 | Usual care n = 233 | Age: M(SD) = 61 (12) Gender: 57% female Race: Not reported | 30% GI, 22% lung, 17% GU, 16% breast, 15% gynecologic | ESAS, QUAL-E, FACIT-Spiritual | 3 months | |
| Temel (2010) USA (MA) N = 151 | RCT | Outpatient consultation team n = 77 | Usual care n = 74 | Age: M(SD) = 65 (10) Gender: 52% female Race: 97% white | 100% lung | FACT-L, PHQ-9, HADS-D, HADS-A | 3, 6, 9, 12, 15, 18, 21, and 24 months, and Kaplan–Meier | |
| Bakitas (2009) USA (NH, VT) N = 322 | RCT | Manualized telehealth support, symptom management, care coordination, and shared medical appointments n = 161 | Usual care n = 161 | Age: M(SD) = 65 (11) Gender: 42% female Race: 99% white | 41% GI, 36% lung, 12% GU, 10% breast | ESAS, FACIT-Palliative, CES-D | 3, 6, 9, 12, 15, 18, 21, and 24 months, and Kaplan–Meier | |
| Preliminary evidence | McCorkle (2015) USA (CT) N = 146 | 4-Cluster RCT | Multidisciplinary outpatient consultation team n = 66 | Usual care n = 80 | Age: M = 60 Gender: 56% female Race: 85% white | 36% GI, 20% gynecologic, 18% head/neck, 25% lung | FACT-G, ESDS, HADS-A, PHQ-9, HDS, SDS | 3 months |
| Higginson (2014) UK (England) N = 21 (105)b | Fast-track RCT | Multidisciplinary outpatient consultation team and home assessment of breathlessness n = 11 (53)b | Usual care for 6 weeks, then delayed access to the intervention n = 10 (52)b | Age: M(SD) = 67 (10) Gender: 42% female Race: Not reported | 62% lung, 14% hematologic, 10% GU, 14% other | None reported | 3 and 6 months | |
| Jordhøy (2001) Norway N = 434 | 6-Cluster RCT | Multidisciplinary outpatient consultation team n = 235 | Usual care n = 199 | Age: Median = 70 Gender: 47% female Race: Not reported | 42% GI, 16% GU, 15% breast/gyn, 12% lung, 15% other | EORTC QLQ-C30 | 3, 6, and 24 months | |
| Excluded from meta-analyses | Rabow (2004) USA (CA) N = 30 (90)b | 2-Cluster RCT | Multidisciplinary outpatient consultation team n = 13 (50)b | Usual care n = 17 (40)b | Age: M(SD) = 69 (13) Gender: 64% female Race: 53% white | Not reported | None reported | None reported |
| Evidencea . | Study . | Design . | Intervention . | Control . | Demographics . | Cancer site . | QOL measures . | Survival . |
|---|---|---|---|---|---|---|---|---|
| High-quality evidence | Temel (2017) USA (MA) N = 350 | RCT | Outpatient consultation team n = 175 | Usual care n = 175 | Age: M(SD) = 65 (11) Gender: 46% female Race: 92% white | 55% lung, 45% GI | FACT-G, PHQ-9, HADS-D, HADS-A | 3 and 6 months |
| Bakitas (2015) USA (NH, VT) N = 207 | Fast-track RCT | Outpatient consultation and manualized telehealth support, symptom management, care coordination, and life review n = 104 | Usual care for 3 months, then delayed access to the intervention n = 103 | Age: M(SD) = 64 (10) Gender: 47% female Race: 97% white | 43% lung, 24% GI, 11% breast, 22% other | FACIT-Palliative, QUAL-E, CES-D | 3, 6, 9, 12 month, and Kaplan–Meier | |
| Zimmermann (2014) Canada N = 461 | 24-Cluster RCT | Outpatient consultation team and access to on-call, inpatient, and home services n = 228 | Usual care n = 233 | Age: M(SD) = 61 (12) Gender: 57% female Race: Not reported | 30% GI, 22% lung, 17% GU, 16% breast, 15% gynecologic | ESAS, QUAL-E, FACIT-Spiritual | 3 months | |
| Temel (2010) USA (MA) N = 151 | RCT | Outpatient consultation team n = 77 | Usual care n = 74 | Age: M(SD) = 65 (10) Gender: 52% female Race: 97% white | 100% lung | FACT-L, PHQ-9, HADS-D, HADS-A | 3, 6, 9, 12, 15, 18, 21, and 24 months, and Kaplan–Meier | |
| Bakitas (2009) USA (NH, VT) N = 322 | RCT | Manualized telehealth support, symptom management, care coordination, and shared medical appointments n = 161 | Usual care n = 161 | Age: M(SD) = 65 (11) Gender: 42% female Race: 99% white | 41% GI, 36% lung, 12% GU, 10% breast | ESAS, FACIT-Palliative, CES-D | 3, 6, 9, 12, 15, 18, 21, and 24 months, and Kaplan–Meier | |
| Preliminary evidence | McCorkle (2015) USA (CT) N = 146 | 4-Cluster RCT | Multidisciplinary outpatient consultation team n = 66 | Usual care n = 80 | Age: M = 60 Gender: 56% female Race: 85% white | 36% GI, 20% gynecologic, 18% head/neck, 25% lung | FACT-G, ESDS, HADS-A, PHQ-9, HDS, SDS | 3 months |
| Higginson (2014) UK (England) N = 21 (105)b | Fast-track RCT | Multidisciplinary outpatient consultation team and home assessment of breathlessness n = 11 (53)b | Usual care for 6 weeks, then delayed access to the intervention n = 10 (52)b | Age: M(SD) = 67 (10) Gender: 42% female Race: Not reported | 62% lung, 14% hematologic, 10% GU, 14% other | None reported | 3 and 6 months | |
| Jordhøy (2001) Norway N = 434 | 6-Cluster RCT | Multidisciplinary outpatient consultation team n = 235 | Usual care n = 199 | Age: Median = 70 Gender: 47% female Race: Not reported | 42% GI, 16% GU, 15% breast/gyn, 12% lung, 15% other | EORTC QLQ-C30 | 3, 6, and 24 months | |
| Excluded from meta-analyses | Rabow (2004) USA (CA) N = 30 (90)b | 2-Cluster RCT | Multidisciplinary outpatient consultation team n = 13 (50)b | Usual care n = 17 (40)b | Age: M(SD) = 69 (13) Gender: 64% female Race: 53% white | Not reported | None reported | None reported |
CES-D Center for Epidemiological Studies Depression Scale; EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire; ESAS Edmonton Symptom Assessment Scale; ESDS Enforced Social Dependency Scale; FACIT Functional Assessment of Chronic Illness Therapy; FACT Functional Assessment of Cancer Therapy (G = General, L = Lung); GI gastrointestinal; GU genitourinary; HADS Hospital Anxiety and Depression Scale; HD Health Distress Scale; PHQ-9 Patient Health Questionnaire; QOL Quality of Life; QUAL-E Quality of Life at End of Life scale; SDS Symptom Distress Scale.
aHigh-quality studies had to have randomization procedures reasonable for avoiding confounding and involve ≥100 cancer patients (see Methods for details).
bParenthetical values indicate samples sizes for all study participants, including those without cancer.
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