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

Primary Purpose

Pancreatic Cancer, Biliary Tract Cancer, Cancer Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Early Palliative care integrated with usual oncologic care
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring pancreatic cancer, biliary tract cancer, cancer pain, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Palliative care

Contol: usual oncologic care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Reduction in pain score
• Reduction in pain scores, Brief Pain Inventory [BPI] severity
Reduction in depression score
Reduction in depression score, Center for Epidemiological Studies-Depression Scale [CES-D]

Secondary Outcome Measures

Quality of life
EORTC QLQ-C30 General Questionnaire, Korean version
Overall survival

Full Information

First Posted
April 25, 2012
Last Updated
January 1, 2018
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01589328
Brief Title
Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
Acronym
EPADE-PB
Official Title
Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 15, 2012 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Biliary Tract Cancer, Cancer Pain, Depression
Keywords
pancreatic cancer, biliary tract cancer, cancer pain, depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Palliative care
Arm Type
Experimental
Arm Description
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
Arm Title
Contol: usual oncologic care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Early Palliative care integrated with usual oncologic care
Other Intervention Name(s)
Contol: usual oncologic care :NONE
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction in pain score
Description
• Reduction in pain scores, Brief Pain Inventory [BPI] severity
Time Frame
at baseline, 1 month, and every 3 months, up to 1 year
Title
Reduction in depression score
Description
Reduction in depression score, Center for Epidemiological Studies-Depression Scale [CES-D]
Time Frame
at baseline, 1 month, and every 3 months, up to 1 year
Secondary Outcome Measure Information:
Title
Quality of life
Description
EORTC QLQ-C30 General Questionnaire, Korean version
Time Frame
at baseline, 1 month, and every 3 months, up to 1 year
Title
Overall survival
Time Frame
at baseline, 1 month, and every 3 months, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Cancer Center
City
Goyang, 410-769
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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