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

Stage IV Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222258
• Other study ID #: HC15C1391-2
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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