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

This study is currently recruiting participants.
Verified October 2012 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Sang Myung Woo, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01589328
First received: April 25, 2012
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pancreatic Cancer
Biliary Tract Cancer
Cancer Pain
Depression
 Other: Early Palliative care integrated with usual oncologic care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Reduction in pain score [ Time Frame: at baseline, 1 month, and every 3 months, up to 1 year ] [ Designated as safety issue: No ]
    • Reduction in pain scores, Brief Pain Inventory [BPI] severity

  • Reduction in depression score [ Time Frame: at baseline, 1 month, and every 3 months, up to 1 year ] [ Designated as safety issue: No ]
    Reduction in depression score, Center for Epidemiological Studies-Depression Scale [CES-D]


Secondary Outcome Measures:
  • Quality of life [ Time Frame: at baseline, 1 month, and every 3 months, up to 1 year ] [ Designated as safety issue: No ]
    EORTC QLQ-C30 General Questionnaire, Korean version

  • Overall survival [ Time Frame: at baseline, 1 month, and every 3 months, up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589328

Contacts
Contact: Sangmyung Woo, MD 82 31 920 1733 wsm@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang, 410-769, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Sangmyung Woo, MD     82 31 920 1733        
Principal Investigator: WooJin Lee, MD            
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Sang Myung Woo, Staff physician, Ceneter for Liver Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01589328     History of Changes
Other Study ID Numbers: NCCCTS-12-605
Study First Received: April 25, 2012
Last Updated: October 17, 2012
Health Authority: National Cancer Center:Korea

Keywords provided by National Cancer Center, Korea:
pancreatic cancer
biliary tract cancer
cancer pain
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Pancreatic Neoplasms
Biliary Tract Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013