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

January 1, 2018 updated by: Sang Myung Woo, National Cancer Center, Korea

Randomized Controlled Trials for the 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, 410-769, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

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

Other Names:
  • Contol: usual oncologic care :NONE
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 early palliative care group or follow the specified palliative care protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in pain score
Time Frame: at baseline, 1 month, and every 3 months, up to 1 year
• 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
Time Frame: at baseline, 1 month, and every 3 months, up to 1 year
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

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

Collaborators and Investigators

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

Sponsor

National Cancer Center, Korea

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 Major Dates

Study Start (ACTUAL)

March 15, 2012

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (ESTIMATE)

May 1, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 1, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-12-605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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