Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB (EPADE-PB)
Pancreatic Cancer, Biliary Tract Cancer, Cancer Pain
About this trial
This is an interventional supportive care trial for Pancreatic Cancer focused on measuring pancreatic cancer, biliary tract cancer, cancer pain, depression
Eligibility Criteria
Inclusion Criteria:
- Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
- Pathologic confirmed locally advanced or metastatic pancreatic cancer or biliary tract cancer
- within 8 weeks after diagnosis
- cancer-related pain (Brief Pain Inventory [BPI] worst pain score >3), depression (Center for Epidemiological Studies-Depression Scale [CES-D] >16) or both
- Karnofsky Performance Rating Scale ≥50%
Exclusion Criteria:
- Opioid intolerance
- History of drug or alcohol abuse
- Impaired sensory or cognitive function
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Early Palliative care
Contol: usual oncologic care
The interventions consisted of the following: (1) Nursing assessment of pain and depression mood (2) Pain control based NCCN guideline (3) Depression control by psychoeducation and/or consultation of psychiatrist specialist (4) Patient education
Patients randomly assigned to usual oncologic care were not scheduled to meet with the palliative care service unless a meeting was requested by the patient, the family, or the oncologist; those who were referred to the service did not cross over to the early palliative care group or follow the specified palliative care protocol.