Effect of Early Management on Pain and Depression in Patients with Pancreatobiliary Cancer: A Randomized Clinical Trial

Abstract

Background: The present study assessed whether early palliative care (EPC) targeting pain and depression and automated symptom monitoring could improve symptoms in patients with advanced pancreatobiliary cancer. Methods: Patients diagnosed with pathologically confirmed locally advanced or metastatic pancreatic or biliary tract cancer who had cancer-related pain (brief pain inventory (BPI) worst pain score >3) and/or depression (Center for Epidemiological Studies—Depression Scale (CES-D) >16) were randomized within 8 weeks after diagnosis to receive EPC or on-demand palliative care (n = 144 each). EPC included (1) nursing assessment of pain and depression, (2) pain control based on National Comprehensive Cancer Network guidelines, (3) depression control by psychoeducation and/or consultation with a psychiatric specialist, and (4) patient education. The primary end points were ≥50% reductions from baseline to week 4 in pain and depression scores. Results: The proportion of patients in the EPC and usual care groups with ≥50% reductions in pain (29.5% vs. 25.2%; p = 0.4194) and depression (30.8% vs. 36.8%; p = 0.5732) scores from baseline to week 4 did not differ significantly. The proportion of patients with BPI worst pain score ≤3 was significantly higher (51.1% vs. 38.9%, p = 0.0404) and the reduction in pain intensity score significantly greater (1.5 vs. 1.0 points, p = 0.0318) in the EPC than in the usual care group. At 4 weeks, patients in the EPC group reported significant increases in global health status, role of functioning, nausea and vomiting, and pain scores on the European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30) general questionnaire. Conclusions: Although the primary outcome was not met, this trial indicates that EPC may improve early pain relief in patients with advanced pancreatobiliary cancers.

Hospital-based specialist palliative care compared with usual care for adults with advanced illness and their caregivers: a systematic review

“…Seven studies recruited from oncology centres or clinics. 35,106,116,148,163,167,168 Two studies 73,129 recruited from oncology clinics of a cancer centre and affiliated outreach clinics, and the Veterans Affairs Medical Center.…”

“…One was carried out in Belgium, 168 one in China, 80 one in Kenya, 97 one in the Republic of Korea, 116 one in Sweden, 118 one in Switzerland, 123 one in Turkey, 95 two in Canada, 79,163 two in Denmark, 104,148 two in Italy 126,147 and three 84,106,160 in Australia. The first study was a US study by Kane et al Studies that were underpowered at recruitment Studies that were adequately powered at recruitment but not at follow-up Studies that were adequately powered both at recruitment and at follow-up Studies that did not report power calculation…”

“…The power of included studies at recruitment and follow-up. Fourteen studies 35,70,82,85,88,89,96,97,116,147,148,156,167,168 carried out post-intervention assessments at the primary end point among > 100 participants.…”

“…Twenty-one studies involved patients with severe/advanced cancer or their caregivers, or both. 35,48,73,75,79,80,85,89,95,101,104,106,116,129,147,148,156,163,167,168,170 Cancers in these studies included solid and non-solid tumours. Seven studies 70,78,82,84,88,142,160 had both cancer and non-cancer populations (mixed diagnoses), whereas the remaining 14 studies had only non-cancer populations.…”

“…Life expectancy in these studies ranged from > 72 hours to 24 months. Eight studies 35,48,73,104,116,147,163,167 stated that they included newly diagnosed patients. Exclusion criteria included palliative care/hospice involvement previously or at present/ request for palliative care involvement 35,70,72,82,84,89,96,106,126,147,163,167,168,176 and presence of severe mental illness.…”