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

March 15, 2021 updated by: Young Ho Yun, Seoul National University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 41199
        • Daegu Fatima Hospital
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 05355
        • Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of, 02447
        • KyungHee University Medical Center
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center, Korea
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Gyeongsangnam-do
      • Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Chonbuk National University Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced stage of cancer (19 years older) and their families at 14 hospitals nationwide in South Korea

Description

[Adult Patients]

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.

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]

Inclusion Criteria:

  • 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Early palliative care for adult
Being referred to palliative care team before totally terminating their chemotherapy among adult participants.
Behavioral: Early palliative care
Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.
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
Routine hospice care for adult
Being referred to palliative care team when their last chemotherapy is ended among adult participants.
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
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
Behavioral: Early palliative care
Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.
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
Unused palliative care for pediatrics
haven't received the palliative care among pediatric participants

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients survival and Physicians Orders for Life Sustaining Treatment (POLST) documentation
Time Frame: Baseline, 3 months, 6 months
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.)
Baseline, 3 months, 6 months
Patient Health Questionnaire-9
Time Frame: Baseline, 3 months, 6 months
"Patient Health Questionnaire-9 items" is used as assessment tool to measure depression of both patients and their caregivers by completing the questionnaire.
Baseline, 3 months, 6 months
Decision Conflict Scale
Time Frame: Baseline, 6 months
"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.
Baseline, 6 months
Understanding the illness
Time Frame: Baseline, 3 months, 6 months
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.
Baseline, 3 months, 6 months
Self-reported Health Status
Time Frame: Baseline, 3 months, 6 months
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.)
Baseline, 3 months, 6 months
KG-7(The Korean Cancer Study Group Geriatric Score)
Time Frame: Baseline, 3 months, 6 months
To measure Daily functional skills in elderly only in 65-year or order patients.
Baseline, 3 months, 6 months
Medical cost in KRW/person/month
Time Frame: 3 months, 6 months
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.
3 months, 6 months
Utilization of healthcare services
Time Frame: 3 months, 6 months
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.
3 months, 6 months
Preference of Advance care and Palliative care
Time Frame: 3 months, 6 months
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.
3 months, 6 months
Mcgill Quality of Life (MQOL)
Time Frame: Baseline, 3 months, 6 months
To measure mental, social, spiritual quality of life of both patients and caregivers
Baseline, 3 months, 6 months
Pediatric Quality of Life Inventory
Time Frame: Baseline, 3 months, 6 months
"Pediatric Quality of Life Inventory(Peds QL)" will be used as assessment tool for QOL among pediatric patients.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Center, Korea
Chonbuk National University Hospital
Asan Medical Center
Chonnam National University Hospital
Ulsan University Hospital
Seoul National University Bundang Hospital
Gyeongsang National University Hospital
Severance Hospital
Ewha Womans University Mokdong Hospital
Keimyung University Dongsan Medical Center
Hallym University Medical Center
Chungnam National University Hospital
Kyunghee University Medical Center
National Evidence-Based Healthcare Collaborating Agency
National Clinical Research Coordination Center, Seoul, Korea
National Institute of Health, Korea
Daegu Fatima Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Young Ho Yun, MD-PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HC15C1391-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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