Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB

National Cancer Center (NCC)

Status: Completed

Conditions: Cancer Pain; Biliary Tract Cancer; Depression; Pancreatic Cancer

Treatments: Other: Early Palliative care integrated with usual oncologic care

Study type: Interventional

Funder types: Other

Identifiers

NCT01589328

NCCCTS-12-605

Details and patient eligibility

About

Effect of Early management on PAin and DEpression in patients with PancreatoBiliary Cancer, EPADE-PB

Purpose

To determine whether early palliative care integrated with usual oncologic care with automated symptom monitoring can improve depression and pain in patients with cancer

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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288 participants in 2 patient groups

Early Palliative care

Experimental group

Description:

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

Treatment:

Other: Early Palliative care integrated with usual oncologic care

Contol: usual oncologic care

No Intervention group

Description:

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.