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Completed

NCT Number: NCT01589328

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

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

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Key information

Conditions

Pancreatic Cancer Behavior Behavioral Symptoms Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Cancer Pain Depression Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center

Goyang, 410-769, Gyeonggi-do, 410-769, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Palliative care integrated with usual oncologic care

Other

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 names: Contol: usual oncologic care :NONE

Primary outcomes

  1. Reduction in pain score

    Time frame: at baseline, 1 month, and every 3 months, up to 1 year

    • Reduction in pain scores, Brief Pain Inventory [BPI] severity

  2. Reduction in depression score

    Time frame: at baseline, 1 month, and every 3 months, up to 1 year

    Reduction in depression score, Center for Epidemiological Studies-Depression Scale [CES-D]

Secondary outcomes

  1. Quality of life

    Time frame: at baseline, 1 month, and every 3 months, up to 1 year

    EORTC QLQ-C30 General Questionnaire, Korean version

  2. Overall survival

    Time frame: at baseline, 1 month, and every 3 months, up to 1 year

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Acronym: EPADE-PB

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 1, 2012
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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