Clinical trial · Interventional
Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
NCT01589328CI-TRIAL-00031019EPADE-PBcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Cancer Pain | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Palliative care integrated with usual oncologic care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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
- interventionNames
- Other: Early Palliative care integrated with usual oncologic care
- type
- NO_INTERVENTION
- label
- Contol: usual oncologic care
- 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.
Primary outcomes (2)
- measure
- Reduction in pain score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.