Systematic vs. on-demand early palliative care in gastric cancer patients : a randomized clinical trial assessing patient and healthcare service outcomes
PURPOSE: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer.
METHODS: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness.
RESULTS: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC.
CONCLUSIONS: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01996540).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
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| Enthalten in: |
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer - 27(2019), 7 vom: 25. Juli, Seite 2425-2434 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Scarpi, Emanuela [VerfasserIn] |
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| Links: |
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| Themen: |
Aggressiveness in end of life |
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| Anmerkungen: |
Date Completed 12.08.2019 Date Revised 25.02.2020 published: Print-Electronic ClinicalTrials.gov: NCT01996540 Citation Status MEDLINE |
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| doi: |
10.1007/s00520-018-4517-2 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM289917336 |
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| 100 | 1 | |a Scarpi, Emanuela |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Systematic vs. on-demand early palliative care in gastric cancer patients |b a randomized clinical trial assessing patient and healthcare service outcomes |
| 264 | 1 | |c 2019 | |
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| 500 | |a Date Completed 12.08.2019 | ||
| 500 | |a Date Revised 25.02.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01996540 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer | ||
| 520 | |a METHODS: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness | ||
| 520 | |a RESULTS: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC | ||
| 520 | |a CONCLUSIONS: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01996540) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Aggressiveness in end of life | |
| 650 | 4 | |a Early palliative care | |
| 650 | 4 | |a Quality of care | |
| 650 | 4 | |a Quality of life | |
| 700 | 1 | |a Dall'Agata, Monia |e verfasserin |4 aut | |
| 700 | 1 | |a Zagonel, Vittorina |e verfasserin |4 aut | |
| 700 | 1 | |a Gamucci, Teresa |e verfasserin |4 aut | |
| 700 | 1 | |a Bertè, Raffaella |e verfasserin |4 aut | |
| 700 | 1 | |a Sansoni, Elisabetta |e verfasserin |4 aut | |
| 700 | 1 | |a Amaducci, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Broglia, Chiara Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Alquati, Sara |e verfasserin |4 aut | |
| 700 | 1 | |a Garetto, Ferdinando |e verfasserin |4 aut | |
| 700 | 1 | |a Schiavon, Stefania |e verfasserin |4 aut | |
| 700 | 1 | |a Quadrini, Silvia |e verfasserin |4 aut | |
| 700 | 1 | |a Orlandi, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Casadei Gardini, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Ruscelli, Silvia |e verfasserin |4 aut | |
| 700 | 1 | |a Ferrari, Daris |e verfasserin |4 aut | |
| 700 | 1 | |a Pino, Maria Simona |e verfasserin |4 aut | |
| 700 | 1 | |a Bortolussi, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Negri, Federica |e verfasserin |4 aut | |
| 700 | 1 | |a Stragliotto, Silvia |e verfasserin |4 aut | |
| 700 | 1 | |a Narducci, Filomena |e verfasserin |4 aut | |
| 700 | 1 | |a Valgiusti, Martina |e verfasserin |4 aut | |
| 700 | 1 | |a Farolfi, Alberto |e verfasserin |4 aut | |
| 700 | 1 | |a Nanni, Oriana |e verfasserin |4 aut | |
| 700 | 1 | |a Rossi, Romina |e verfasserin |4 aut | |
| 700 | 1 | |a Maltoni, Marco |e verfasserin |4 aut | |
| 700 | 0 | |a Early Palliative Care Italian Study Group (EPCISG) |e verfasserin |4 aut | |
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