NCT01589328

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

January 3, 2018

Status Verified

January 1, 2018

Enrollment Period

5.3 years

First QC Date

April 25, 2012

Last Update Submit

January 1, 2018

Conditions

Pancreatic CancerBiliary Tract CancerCancer PainDepression

Keywords

pancreatic cancerbiliary tract cancercancer paindepression

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Quality of life

    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

Study Arms (2)

Early Palliative care

EXPERIMENTAL

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

Contol: usual oncologic care

NO INTERVENTION

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.

Interventions

Early Palliative care integrated with usual oncologic careOTHER

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

Also known as: Contol: usual oncologic care :NONE
Early Palliative care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

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

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsBiliary Tract NeoplasmsCancer PainDepression

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff physician, Ceneter for Liver Cancer

Study Record Dates

First Submitted

April 25, 2012

First Posted

May 1, 2012

Study Start

March 15, 2012

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

January 3, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)