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

Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01589328

Acronym

EPADE-PB

Enrollment

288

Registered

2012-05-01

Start date

2012-03-15

Completion date

2017-06-30

Last updated

2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer, Cancer Pain, Depression, Pancreatic Cancer

Keywords

pancreatic cancer, biliary tract cancer, cancer pain, depression

Brief summary

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

Interventions

OTHEREarly Palliative care integrated with usual oncologic care

Drug: 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction in pain score	at baseline, 1 month, and every 3 months, up to 1 year	• Reduction in pain scores, Brief Pain Inventory \[BPI\] severity
Reduction in depression score	at baseline, 1 month, and every 3 months, up to 1 year	Reduction in depression score, Center for Epidemiological Studies-Depression Scale \[CES-D\]

Secondary

Measure	Time frame	Description
Quality of life	at baseline, 1 month, and every 3 months, up to 1 year	EORTC QLQ-C30 General Questionnaire, Korean version
Overall survival	at baseline, 1 month, and every 3 months, up to 1 year	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026