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

Not Applicable

Completed

• Conditions: Cancer Pain; Pancreatic Cancer; Biliary Tract Cancer; Depression
• Interventions: Other: Early Palliative care integrated with usual oncologic care

• Registration Number: NCT01589328
• Lead Sponsor: National Cancer Center, Korea

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-15
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-01
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Palliative care	Early Palliative care integrated with 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

Primary Outcome Measures

Name	Time	Method
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 \[CES-D\]
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, 410-769, Gyeonggi-do, Korea, Republic of