Randomized Controlled Trial of Integrated Early Palliative Care
NCT ID: NCT03181854
Last Updated: 2019-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2017-09-08
2019-06-30
Brief Summary
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Detailed Description
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This study aims to evaluate the effect of the introduction of early palliative care services to advanced cancer patients. Eligible patients are 20 years or older, and has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor, a European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months or less. The primary goal of an integrated early palliative care program is to improve the overall quality of life of patients and their families. Secondarily, it is to help understand the disease, resolving conflicts in the decision-making process, improving the crisis coping capacity, and further determining the patient's and family's advanced care planning. At last, it is desired to evaluate the effect of the program on overall medical cost savings and 1 year survival.
Participants of the study will be allocated in the intervention group and the control group equally. Within three weeks from the time of randomization, the first meeting with a palliative care team will be held. In the time of baseline questionnaire, patients will be provided with self-study education materials and videos on the early palliative care and advance care planning. Once in every three weeks for six months, which is the duration for one treatment course, palliative care for advance care planning, symptom control, and other mental, social and spiritual problems will be provided. After the first meeting with the palliative care team, telephone coaching will be performed once a week for the first 12 weeks and then every two weeks until the end of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group
Consultation with PCT doctor every 3 weeks. Telephone coaching once a week for 3 months and once in 2 weeks for another 3 months.
Telephone coaching
Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months.
Consultation with PCT doctor
Consultation with PCT physician every 3 weeks.
Control Group
Usual palliative care can be provided if desired.
No interventions assigned to this group
Interventions
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Telephone coaching
Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months.
Consultation with PCT doctor
Consultation with PCT physician every 3 weeks.
Eligibility Criteria
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Inclusion Criteria
* Subject who has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor
* Subject whose ECOG performance status is between 0 to 2.
* Subject with an estimated life expectancy of 12 months and less (assessed by the treating oncologist)
* Subject who volunteers
Exclusion Criteria
* Medical conditions that would limit adherence to participation of the clinical trial(as confirmed by their referring physician; e.g. dyspnea)
* Suspension of all cancer treatment
* Palliative care consultation at any time or in palliative care
20 Years
ALL
No
Sponsors
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National Evidence-Based Healthcare Collaborating Agency
OTHER_GOV
National Institute of Health, Korea
OTHER_GOV
National Clinical Research Coordination Center, Seoul, Korea
OTHER_GOV
Seoul National University Bundang Hospital
OTHER
Severance Hospital
OTHER
Gyeongsang National University Hospital
OTHER
Chungnam National University Hospital
OTHER
Chonbuk National University Hospital
OTHER
Daegu Fatima Hospital
OTHER
Hallym University Medical Center
OTHER
Korea University Guro Hospital
OTHER
Asan Medical Center
OTHER
Chonnam National University Hospital
OTHER
Ewha Womans University Mokdong Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Ulsan University Hospital
OTHER
Pohang Semyeong Christianity Hospital
UNKNOWN
Gangneung Asan Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Young Ho Yun
Principal Investigator
Principal Investigators
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Young Ho Yun, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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References
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Jung JY, Yun JY, Kang JH, Koh SJ, Kim YJ, Seo S, Kim JH, Cheon J, Kang EJ, Song EK, Nam EM, Oh HS, Choi HJ, Kwon JH, Bae WK, Lee JE, Jung KH, Kang E, Yun YH. Interaction effect of comorbid depression and proactive positivity coping strategy on the 1-year survival of patients with advanced cancer: a nationwide multicentre study in South Korea. BMC Psychiatry. 2025 Jun 2;25(1):565. doi: 10.1186/s12888-025-06972-4.
Kang E, Kang JH, Koh SJ, Kim YJ, Seo S, Kim JH, Cheon J, Kang EJ, Song EK, Nam EM, Oh HS, Choi HJ, Kwon JH, Bae WK, Lee JE, Jung KH, Yun YH. Early Integrated Palliative Care in Patients With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2426304. doi: 10.1001/jamanetworkopen.2024.26304.
Other Identifiers
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HC15C1391-1
Identifier Type: -
Identifier Source: org_study_id
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