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

Study Overview
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Brief Summary
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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

Official Title
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Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB

Conditions
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Pancreatic Cancer, Biliary Tract Cancer, Cancer Pain, Depression

Intervention / Treatment
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* Other: Early Palliative care integrated with usual oncologic care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Palliative care<br>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<br>* 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<br>* Other names: Contol: usual oncologic care :NONE;|
| No Intervention: Contol: usual oncologic care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain score | • 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 | 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 | EORTC QLQ-C30 General Questionnaire, Korean version | at baseline, 1 month, and every 3 months, up to 1 year | 
| Overall survival |  | at baseline, 1 month, and every 3 months, up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, biliary tract cancer, cancer pain, depression