Brief Title
Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
Official Title
Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
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
Study Type
Interventional
Primary Outcome
Reduction in pain score
Secondary Outcome
Quality of life
Condition
Pancreatic Cancer
Intervention
Early Palliative care integrated with usual oncologic care
Study Arms / Comparison Groups
Early Palliative care
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
288
Start Date
March 15, 2012
Completion Date
June 30, 2017
Primary Completion Date
June 30, 2017
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01589328
Organization ID
NCCCTS-12-605
Responsible Party
Principal Investigator
Study Sponsor
National Cancer Center, Korea
Study Sponsor
, ,
Verification Date
January 2018