Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients

NCT ID: NCT03222258

Last Updated: 2021-03-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

444 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-17

Study Completion Date

2020-04-30

Brief Summary

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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

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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

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Stage IV Breast Cancer Stage IV Pancreatic Cancer Stage IV Colon Cancer Stage IV Gastric Cancer Stage IV Lung Cancer Stage IV Liver Cancer Malignant Hematologic Neoplasm Biliary Cancer Metastatic Pediatric Leukemia Pediatric Lymphoma Pediatric Brain Tumor Pediatric Solid Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early palliative care for adult

Being referred to palliative care team before totally terminating their chemotherapy among adult participants.

Early palliative care

Intervention Type BEHAVIORAL

Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.

Routine hospice care

Intervention Type BEHAVIORAL

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

Routine hospice care for adult

Being referred to palliative care team when their last chemotherapy is ended among adult participants.

Routine hospice care

Intervention Type BEHAVIORAL

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

Unused palliative care for adult

haven't been under the palliative care among adult participants

No interventions assigned to this group

Palliative care for pediatrics

receiving the palliative care among pediatric participants

Early palliative care

Intervention Type BEHAVIORAL

Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.

Routine hospice care

Intervention Type BEHAVIORAL

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

Unused palliative care for pediatrics

haven't received the palliative care among pediatric participants

No interventions assigned to this group

Interventions

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Early palliative care

Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.

Intervention Type BEHAVIORAL

Routine hospice care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Gyeongsang National University Hospital

OTHER

Sponsor Role collaborator

Chungnam National University Hospital

OTHER

Sponsor Role collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role collaborator

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role collaborator

Daegu Fatima Hospital

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role collaborator

National Evidence-Based Healthcare Collaborating Agency

OTHER_GOV

Sponsor Role collaborator

National Institute of Health, Korea

OTHER_GOV

Sponsor Role collaborator

National Clinical Research Coordination Center, Seoul, Korea

OTHER_GOV

Sponsor Role collaborator

Ulsan University Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Ho Yun

Clinical Professor

Responsibility Role 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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National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Site Status

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Site Status

Daegu Fatima Hospital

Daegu, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Kyunghee University Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 39582048 (View on PubMed)

Other Identifiers

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HC15C1391-2

Identifier Type: -

Identifier Source: org_study_id

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