Clinical trial NCT03222258: Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: Palliative Care
Quality of Life
Prospective Cohort Study
Treatment decision
Utilization of health care
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: National Cancer Center, Korea
name: Kyunghee University Medical Center
name: Severance Hospital
name: Gyeongsang National University Hospital
name: Chungnam National University Hospital
name: Chonbuk National University Hospital
name: Ewha Womans University Mokdong Hospital
name: Daegu Fatima Hospital
name: Chonnam National University Hospital
name: Keimyung University Dongsan Medical Center
name: Hallym University Medical Center
name: Asan Medical Center
name: National Evidence-Based Healthcare Collaborating Agency
name: National Institute of Health, Korea
name: National Clinical Research Coordination Center, Seoul, Korea
name: Ulsan University Hospital
First posted: 2017-07-19
Enrollment: 444
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: \[Adult Patients\]

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

Primary outcomes:
measure: Change from baseline Overall QOL of EORTC QLQ - Core 15 at 6 months items
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Patients survival and Physicians Orders for Life Sustaining Treatment (POLST) documentation
timeFrame: Baseline, 3 months, 6 months
measure: Patient Health Questionnaire-9
timeFrame: Baseline, 3 months, 6 months
measure: Decision Conflict Scale
timeFrame: Baseline, 6 months
measure: Understanding the illness
timeFrame: Baseline, 3 months, 6 months
measure: Self-reported Health Status
timeFrame: Baseline, 3 months, 6 months
measure: KG-7(The Korean Cancer Study Group Geriatric Score)
timeFrame: Baseline, 3 months, 6 months
measure: Medical cost in KRW/person/month
timeFrame: 3 months, 6 months
measure: Utilization of healthcare services
timeFrame: 3 months, 6 months
measure: Preference of Advance care and Palliative care
timeFrame: 3 months, 6 months
measure: Mcgill Quality of Life (MQOL)
timeFrame: Baseline, 3 months, 6 months
measure: Pediatric Quality of Life Inventory
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Ho Yun, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: