Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
NCT ID: NCT01589328
Last Updated: 2018-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
288 participants
INTERVENTIONAL
2012-03-15
2017-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
No interventions assigned to this group
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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Sang Myung Woo
Staff physician, Ceneter for Liver Cancer
Locations
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National Cancer Center
Goyang, 410-769, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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NCCCTS-12-605
Identifier Type: -
Identifier Source: org_study_id
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