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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03222258
Other study ID # HC15C1391-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 17, 2016
Est. completion date April 30, 2020

Study information

Verified date March 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 444
Est. completion date April 30, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility [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 Design


Intervention

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

Locations

Country Name City State
Korea, Republic of Daegu Fatima Hospital Daegu
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of National Cancer Center, Korea Goyang-si Gyeonggi-do
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun Jeollanam-do
Korea, Republic of Chonbuk National University Hospital Jeonju Jeollabuk-do
Korea, Republic of Gyeongsang National University Hospital Jinju-si Gyeongsangnam-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul
Korea, Republic of Kangdong Sacred Heart Hospital Seoul
Korea, Republic of Kyunghee University Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of Ulsan University Hospital Ulsan

Sponsors (18)

Lead Sponsor Collaborator
Seoul National University Hospital Asan Medical Center, Chonbuk National University Hospital, Chonnam National University Hospital, Chungnam National University Hospital, Daegu Fatima Hospital, Ewha Womans University Mokdong Hospital, Gyeongsang National University Hospital, Hallym University Medical Center, Keimyung University Dongsan Medical Center, Kyunghee University Medical Center, National Cancer Center, Korea, National Clinical Research Coordination Center, Seoul, Korea, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, Seoul National University Bundang Hospital, Severance Hospital, Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Mcgill Quality of Life (MQOL) To measure mental, social, spiritual quality of life of both patients and caregivers Baseline, 3 months, 6 months
Secondary 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
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