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

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: Completed
• Conditions: Stage IV Lung Cancer; Stage IV Pancreatic Cancer; Stage IV Breast Cancer; Pediatric Brain Tumor; Stage IV Colon Cancer; Stage IV Gastric Cancer; Stage IV Liver Cancer; Malignant Hematologic Neoplasm; Pediatric Solid Tumor; Pediatric Lymphoma; Biliary Cancer Metastatic; Pediatric Leukemia
• Intervention / Treatment: Behavioral: Early palliative care; Behavioral: Routine hospice care

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: Observational
• Enrollment (Actual): 444

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	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.	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.	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.	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.)	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.	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.	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.	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.	3 months, 6 months
Mcgill Quality of Life (MQOL)	To measure mental, social, spiritual quality of life of both patients and caregivers	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.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: 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: Principal Investigator: Young Ho Yun, MD-PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2016
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: July 16, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Palliative Care; Prospective Cohort Study; Treatment decision; Utilization of health care
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID 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