Stage IV Breast CancerNCT03222258
Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients
An observational study of Stage IV Breast Cancer and Stage IV Pancreatic Cancer, run by Seoul National University Hospital at 15 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage IV Breast Cancer, Stage IV Pancreatic Cancer, Stage IV Colon Cancer
- What is being tested?
- Early palliative care and Routine hospice care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 444 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 17 Dec 2016to 30 Apr 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced stage of cancer (19 years older) and their families at 14 hospitals nationwide in South Korea
Who may be able to join
- 19 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.
- 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.
Who cannot join
- 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]
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Daegu Fatima Hospital
Daegu, 41199
Keimyung University Dongsan Medical Center
Daegu, 41931
Chungnam National University Hospital
Daejeon, 35015
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 10408
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Kyunghee University Medical Center
Seoul, 02447
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Kangdong Sacred Heart Hospital
Seoul, 05355
Asan Medical Center
Seoul, 05505
Ewha Womans University Mokdong Hospital
Seoul, 07985
Ulsan University Hospital
Ulsan, 44033
About this study
Official title: 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
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.
Read the detailed description
Patients with advanced cancer report physical, emotional, social and economic problems that may be due to the cancer itself or its treatment. Previous studies have shown the benefit of early palliative care in oncology. However, many Korean patients tend to start palliative care late even in general hospital. Because of the late start of palliative care, the burden of medical expenses increases, on the other hand, the quality of life of terminally ill patients decrease.
In this study, the use of palliative care in advanced cancer patients will be evaluated by a prospective cohort study. The goals of this study are as follow:
First, the clinical, psycho-social, and cognitive factors affecting quality of life, decision making, and hospital utilization (palliative medical team medical treatment, hospice and medical care) of patients with advanced stage cancer will be investigated.
Second, this study will explore the effects of age-specific characteristics on quality of life and care.
Third, an index, which reflects age-specific characteristics and predicts the time and content of terminal care will be developed. Improvements on the quality of life and care of patients with advanced stage of cancer or metastatic cancer are expected to establish effective terminal care strategies through this study.
The patients' symptom and quality of life, choice of medical care, advance care planning and caregiver's burden of care will be evaluated every 3 months after confirming the willingness to use palliative care for cancer patients. 3 months after the death, a caregiver evaluation will be conducted and hospice use, medical expenses will be analyzed.
- Conditions
- Stage IV Breast Cancer, Stage IV Pancreatic Cancer, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Lung Cancer, Stage IV Liver Cancer
- Being tested
- Early palliative care, Routine hospice care
- Keywords
- Palliative Care, Quality of Life, Prospective Cohort Study, Treatment decision, Utilization of health care
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Stomach Neoplasms, Lung Neoplasms, Liver Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early palliative careBehavioural
Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.
Routine hospice careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Early palliative care for adult | Being referred to palliative care team before totally terminating their chemotherapy among adult participants. Receives: Behavioral: Early palliative care; Behavioral: Routine hospice care | |
| Routine hospice care for adult | Being referred to palliative care team when their last chemotherapy is ended among adult participants. Receives: Behavioral: Routine hospice care | |
| 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 Receives: Behavioral: Early palliative care; Behavioral: Routine hospice care | |
| Unused palliative care for pediatrics | haven't received the palliative care among pediatric participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3 months, 6 months
Secondary outcomes (11)
Patients survival and Physicians Orders for Life Sustaining Treatment (POLST) documentation
Patients survival and POLST(Physician Order for Life-Sustaining Treatment) documentation whether patients survive during the study period and write POLST documentation (Since POLST has no legal form in Korea, it is based on the format of each institution.)
Measured: Baseline, 3 months, 6 months
Patient Health Questionnaire-9
"Patient Health Questionnaire-9 items" is used as assessment tool to measure depression of both patients and their caregivers by completing the questionnaire.
Measured: Baseline, 3 months, 6 months
Decision Conflict Scale
"Decision Conflict Scale" is used as assessment tool to measure a level of decision conflict in treatment of both patients and their caregivers by completing the questionnaire.
Measured: Baseline, 6 months
Understanding the illness
to measure the awareness of patients' status of prognosis in both patients and caregivers through two questions in the questionnaire. The first question is about the idea of the possibility of curing the patient's disease and asks patients thought about whether treatment is available for cure and prolong survival. The second question concerns the life expectancy of the patient.
Measured: Baseline, 3 months, 6 months
Self-reported Health Status
to measure the perceived holistic health status(physical, mental, social, spiritual and general) in both patients and caregivers. caregivers (The patient is asked to answer the perceived health status into five stages.)
Measured: Baseline, 3 months, 6 months
KG-7(The Korean Cancer Study Group Geriatric Score)
To measure Daily functional skills in elderly only in 65-year or order patients.
Measured: Baseline, 3 months, 6 months
Medical cost in KRW/person/month
Direct medical cost will be collected through National Health Insurance Corporation and Indirect cost will be collected by caregiver's questionnaire. In addition, "EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L)" tool will be included in the patient's questionnaire to measure the condition of patients at the same time.
Measured: 3 months, 6 months
Utilization of healthcare services
In order to analyze the cost effectiveness, investigate the frequency of use of early palliative care programs, the use of life-sustaining treatment and hospicee, and the use of complementary and alternative medicine(CAM). CAM include Chinese medicine, aromatherapy, diet, and yoga, etc.
Measured: 3 months, 6 months
Preference of Advance care and Palliative care
to assess the patient's awareness of advanced care planning and willingness to construct advanced care planning. The preference for palliative care is divided according to the life expectancy. Investigate the preference of palliative care in each case - if the life expectancy is within a year, within a few months, or within a few weeks.
Measured: 3 months, 6 months
Mcgill Quality of Life (MQOL)
To measure mental, social, spiritual quality of life of both patients and caregivers
Measured: Baseline, 3 months, 6 months
Pediatric Quality of Life Inventory
"Pediatric Quality of Life Inventory(Peds QL)" will be used as assessment tool for QOL among pediatric patients.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start17 Dec 2016
- Primary completion31 Oct 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, National Cancer Center, Korea, Kyunghee University Medical Center, Severance Hospital, Gyeongsang National University Hospital, Chungnam National University Hospital, Chonbuk National University Hospital, Ewha Womans University Mokdong Hospital, Daegu Fatima Hospital, Chonnam National University Hospital, Keimyung University Dongsan Medical Center, Hallym University Medical Center, Asan Medical Center, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Ulsan University Hospital
- Responsible party
- Principal investigator, Young Ho Yun, Seoul National University Hospital
- Investigators
- Young Ho Yun, MD-PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222258
- Sponsor's protocol ID
- HC15C1391-2
- Status last verified
- Mar 2021
- First submitted
- 5 Jun 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39582048
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03222258
- Acronym / sponsor ID
- HC15C1391-2
- Conditions
- Stage IV Breast Cancer, Stage IV Pancreatic Cancer, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Lung Cancer, Stage IV Liver Cancer
- Keywords
- Palliative Care, Quality of Life, Prospective Cohort Study, Treatment decision, Utilization of health care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, National Cancer Center, Korea, Kyunghee University Medical Center, Severance Hospital, Gyeongsang National University Hospital, Chungnam National University Hospital, Chonbuk National University Hospital, Ewha Womans University Mokdong Hospital, Daegu Fatima Hospital, Chonnam National University Hospital, Keimyung University Dongsan Medical Center, Hallym University Medical Center, Asan Medical Center, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Ulsan University Hospital
- Study start
- 17 Dec 2016 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 19 Jul 2017 (actual)
- 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.
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.
Detailed description
Patients with advanced cancer report physical, emotional, social and economic problems that may be due to the cancer itself or its treatment. Previous studies have shown the benefit of early palliative care in oncology. However, many Korean patients tend to start palliative care late even in general hospital. Because of the late start of palliative care, the burden of medical expenses increases, on the other hand, the quality of life of terminally ill patients decrease.
In this study, the use of palliative care in advanced cancer patients will be evaluated by a prospective cohort study. The goals of this study are as follow:
First, the clinical, psycho-social, and cognitive factors affecting quality of life, decision making, and hospital utilization (palliative medical team medical treatment, hospice and medical care) of patients with advanced stage cancer will be investigated.
Second, this study will explore the effects of age-specific characteristics on quality of life and care.
Third, an index, which reflects age-specific characteristics and predicts the time and content of terminal care will be developed. Improvements on the quality of life and care of patients with advanced stage of cancer or metastatic cancer are expected to establish effective terminal care strategies through this study.
The patients' symptom and quality of life, choice of medical care, advance care planning and caregiver's burden of care will be evaluated every 3 months after confirming the willingness to use palliative care for cancer patients. 3 months after the death, a caregiver evaluation will be conducted and hospice use, medical expenses will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Early palliative care for adult | – | Behavioral: Early palliative care, Behavioral: Routine hospice careBeing referred to palliative care team before totally terminating their chemotherapy among adult participants. |
| Routine hospice care for adult | – | Behavioral: Routine hospice careBeing 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 | – | Behavioral: Early palliative care, Behavioral: Routine hospice carereceiving the palliative care among pediatric participants |
| Unused palliative care for pediatrics | – | –haven't received the palliative care among pediatric participants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced stage of cancer (19 years older) and their families at 14 hospitals nationwide in South Korea
Key inclusion criteria (8 listed)
- 19 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.
- Who was diagnosed as pediatric cancer between 0-18 years of age.
Key exclusion criteria (7 listed)
- 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]
- Parents of patient are unable to participate due to poor cognitive capacity
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 carePalliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist. | Behavioural | Early palliative care for adult, Palliative care for pediatrics |
| Routine hospice carePalliative Care Team provide a routine hospice care the same as other patients who doesn't participate this study after the chemotherapy is totally terminated | Behavioural | Early palliative care for adult, Palliative care for pediatrics, Routine hospice care for adult |
Primary outcome
Change from baseline Overall QOL of EORTC QLQ - Core 15 at 6 months items
Time frame: Baseline, 3 months, 6 months
to measure quality of life of adult patients developed by European Organisation for Research and Treatment of Cancer for Palliative Care
11 secondary outcomes
Patients survival and Physicians Orders for Life Sustaining Treatment (POLST) documentation
Time frame: Baseline, 3 months, 6 months
Patient Health Questionnaire-9
Time frame: Baseline, 3 months, 6 months
Decision Conflict Scale
Time frame: Baseline, 6 months
Understanding the illness
Time frame: Baseline, 3 months, 6 months
Self-reported Health Status
Time frame: Baseline, 3 months, 6 months
KG-7(The Korean Cancer Study Group Geriatric Score)
Time frame: Baseline, 3 months, 6 months
Medical cost in KRW/person/month
Time frame: 3 months, 6 months
Utilization of healthcare services
Time frame: 3 months, 6 months
Preference of Advance care and Palliative care
Time frame: 3 months, 6 months
Mcgill Quality of Life (MQOL)
Time frame: Baseline, 3 months, 6 months
Pediatric Quality of Life Inventory
Time frame: Baseline, 3 months, 6 months
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 17 Mar 2021.
- Derived from this study: PubMed 39582048Yun 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.
- Individual participant dataSharing planned: Undecided
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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.
Young Ho Yun, MD-PhD principal investigator
Seoul National University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IV Breast Cancer and Stage IV Pancreatic Cancer, run by Seoul National University Hospital at 15 sites 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 8 inclusion and 7 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Change from baseline Overall QOL of EORTC QLQ - Core 15 at 6 months items (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222258, which also lists 1 linked publication.
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 17 Mar 2021.