Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients
Change of Quality of Life, Treatment Decision and Utilization of Health Care Depending on the Use of Palliative Care in Adult and Pediatric Patients With Advanced Stage of Cancer: a Prospective Cohort Study
1 other identifier
observational
444
1 country
15
Brief Summary
This study evaluates the change of quality of life, treatment decision and utilization of health care depending on the use of palliative care in advanced cancer patients by a prospective cohort study. Participants will be separated into different groups by their intentions for using palliative care. Every participant will carry out the questionnaire per 3 months. This cohort study will be ended a year after each participant enrolls. However, if the participant didn't survive during this study, the caregivers will be asked to fill out additional questionnaire after 3 months of the death.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Typical duration for all trials
15 active sites
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
December 17, 2016
CompletedFirst Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMarch 17, 2021
March 1, 2021
2.9 years
June 5, 2017
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Overall QOL of EORTC QLQ - Core 15 at 6 months items
to measure quality of life of adult patients developed by European Organisation for Research and Treatment of Cancer for Palliative Care
Baseline, 3 months, 6 months
Secondary Outcomes (11)
Patients survival and Physicians Orders for Life Sustaining Treatment (POLST) documentation
Baseline, 3 months, 6 months
Patient Health Questionnaire-9
Baseline, 3 months, 6 months
Decision Conflict Scale
Baseline, 6 months
Understanding the illness
Baseline, 3 months, 6 months
Self-reported Health Status
Baseline, 3 months, 6 months
- +6 more secondary outcomes
Study Arms (5)
Early palliative care for adult
Being referred to palliative care team before totally terminating their chemotherapy among adult participants.
Routine hospice care for adult
Being referred to palliative care team when their last chemotherapy is ended among adult participants.
Unused palliative care for adult
haven't been under the palliative care among adult participants
Palliative care for pediatrics
receiving the palliative care among pediatric participants
Unused palliative care for pediatrics
haven't received the palliative care among pediatric participants
Interventions
Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.
Palliative Care Team provide a routine hospice care the same as other patients who doesn't participate this study after the chemotherapy is totally terminated
Eligibility Criteria
Patients with advanced stage of cancer (19 years older) and their families at 14 hospitals nationwide in South Korea
You may qualify if:
- years of age or older and diagnosed as cancer older than 19 years of age
- Stage 4 of advanced Breast Cancer, Colon cancer, gastric cancer, pancreatobiliary cancer, lung cancer, Liver Cancer or Malignant hematologic neoplasm
- Patients under one of the following status : 1) under the standard chemotherapy, 2) interrupted state of standard chemotherapy, 3) under the additional chemotherapy after standard chemotherapy, 4) terminating state of any chemotherapy yet expected to be survive more than 6 months.
- who understand the purpose and method of the study and sign with informed consent form.
You may not qualify if:
- who are unable to participate due to poor cognitive capacity
- who cannot read or understand Korean language
- who are unable to complete surveys due to physical conditions
- \[Pediatric Patients\]
- Who was diagnosed as pediatric cancer between 0-18 years of age.
- Younger than 30 years of age
- Patients under one of the following status : 1)recurrence after 2nd standard chemotherapy or without remission in leukemia, 2) recurrence after stem cell transplantation, 3) diagnosed as the cancer of poor prognosis : ATRT, glioblastoma multiforme, brainstem glioma etc.
- Patients or their proxy understand the purpose and method of the study and sign with informed consent form.
- Parents of patient are unable to participate due to poor cognitive capacity
- Parents of patient do not have legal responsibility or rights of the patient
- Parents of patients cannot speak, read or understand Korean language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Seoul National University Bundang Hospitalcollaborator
- National Cancer Center, Koreacollaborator
- Kyunghee University Medical Centercollaborator
- Severance Hospitalcollaborator
- Gyeongsang National University Hospitalcollaborator
- Chungnam National University Hospitalcollaborator
- Chonbuk National University Hospitalcollaborator
- Ewha Womans University Mokdong Hospitalcollaborator
- Daegu Fatima Hospitalcollaborator
- Chonnam National University Hospitalcollaborator
- Keimyung University Dongsan Medical Centercollaborator
- Hallym University Medical Centercollaborator
- Asan Medical Centercollaborator
- National Evidence-Based Healthcare Collaborating Agencycollaborator
- National Institute of Health, Koreacollaborator
- National Clinical Research Coordination Center, Seoul, Koreacollaborator
- Ulsan University Hospitalcollaborator
Study Sites (15)
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128, South Korea
Daegu Fatima Hospital
Daegu, 41199, South Korea
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Kyunghee University Medical Center
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Kangdong Sacred Heart Hospital
Seoul, 05355, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Related Publications (1)
Yun JY, Jung JY, Keam B, Lee NR, Kang JH, Kim YJ, Shim HJ, Jung KH, Koh SJ, Ryu H, Yoo SH, Kang E, Yun YH. Depression, performance status, and discontinued treatment mediate an association of curability belief with prognosis in advanced cancer patients. Sci Rep. 2024 Nov 24;14(1):29098. doi: 10.1038/s41598-024-80687-6.
PMID: 39582048DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Ho Yun, MD-PhD
Seoul National University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 5, 2017
First Posted
July 19, 2017
Study Start
December 17, 2016
Primary Completion
October 31, 2019
Study Completion
April 30, 2020
Last Updated
March 17, 2021
Record last verified: 2021-03