Pancreatic CancerEPADE-PBNCT01589328
Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
A study testing Early Palliative care integrated with usual oncologic care in people with Pancreatic Cancer and Biliary Tract Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Biliary Tract Cancer, Cancer Pain
- What is being tested?
- Early Palliative care integrated with usual oncologic care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2012to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center
Goyang, 410-769, Gyeonggi-do, 410-769
About this study
Official title: Randomized Controlled Trials for the 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
- Conditions
- Pancreatic Cancer, Biliary Tract Cancer, Cancer Pain, Depression
- Being tested
- Early Palliative care integrated with usual oncologic care
- Keywords
- pancreatic cancer, biliary tract cancer, cancer pain, depression
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Cancer Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Palliative care integrated with usual oncologic careOther
Also called Contol: usual oncologic care :NONE
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain score
- Reduction in pain scores, Brief Pain Inventory [BPI] severity
Measured: 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]
Measured: at baseline, 1 month, and every 3 months, up to 1 year
Secondary outcomes (2)
Quality of life
EORTC QLQ-C30 General Questionnaire, Korean version
Measured: at baseline, 1 month, and every 3 months, up to 1 year
Overall survival
Measured: at baseline, 1 month, and every 3 months, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study start15 Mar 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sang Myung Woo, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589328
- Sponsor's protocol ID
- NCCCTS-12-605
- Acronym
- EPADE-PB
- Status last verified
- Jan 2018
- First submitted
- 25 Apr 2012
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
- ClinicalTrials.gov ID
- NCT01589328
- Acronym / sponsor ID
- EPADE-PB / NCCCTS-12-605
- Conditions
- Pancreatic Cancer, Biliary Tract Cancer, Cancer Pain, Depression
- Keywords
- pancreatic cancer, biliary tract cancer, cancer pain, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 15 Mar 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Palliative care | Experimental | Other: Early Palliative care integrated with usual oncologic careThe 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Palliative care integrated with usual oncologic careAlso: Contol: usual oncologic care :NONEDrug: 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 |
Primary outcome
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
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]
2 secondary outcomes
Quality of life
Time frame: at baseline, 1 month, and every 3 months, up to 1 year
Overall survival
Time frame: at baseline, 1 month, and every 3 months, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Palliative care integrated with usual oncologic care in people with Pancreatic Cancer and Biliary Tract Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain score (time frame: at baseline, 1 month, and every 3 months, up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.