Effect Of Early Management On PAin And DEpression In Patients With PancreatoBiliary Cancer, EPADE-PB

Study Overview

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

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

N/A

Pancreatic Cancer
Biliary Tract Cancer
Cancer Pain
Depression

OTHER: Early Palliative care integrated with usual oncologic care

NCCCTS-12-605

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-04-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-01-01
First Submitted that Met QC Criteria 2012-04-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-01-03
First Posted (ACTUAL) 2012-05-01	Results First Posted N/A	Last Verified 2018-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Early Palliative 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	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
NO_INTERVENTION: Contol: usual oncologic care 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 e

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Early Palliative 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

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

NO_INTERVENTION: Contol: usual oncologic care

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 e

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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%

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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