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

Depression Clinical Trial

— EPADE-PB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589328
• Other study ID #: NCCCTS-12-605
• Status: Completed
• Phase: N/A
• First received: April 25, 2012
• Last updated: January 1, 2018
• Start date: March 15, 2012
• Est. completion date: June 30, 2017

Study information

• Verified date: January 2018
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cancer Pain
• Depression
• Depressive Disorder
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Early 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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang, 410-769	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in pain score	• Reduction in pain scores, Brief Pain Inventory [BPI] severity	at baseline, 1 month, and every 3 months, up to 1 year
Primary	Reduction in depression score	Reduction in depression score, Center for Epidemiological Studies-Depression Scale [CES-D]	at baseline, 1 month, and every 3 months, up to 1 year
Secondary	Quality of life	EORTC QLQ-C30 General Questionnaire, Korean version	at baseline, 1 month, and every 3 months, up to 1 year
Secondary	Overall survival		at baseline, 1 month, and every 3 months, up to 1 year