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

Seoul National University

Status: Completed

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

Treatments: Behavioral: Early palliative care; Behavioral: Routine hospice care

Study type: Observational

Funder types: Other

Identifiers

NCT03222258

HC15C1391-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 444 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

444 participants in 5 patient groups

Early palliative care for adult

Description:

Being referred to palliative care team before totally terminating their chemotherapy among adult participants.

Treatment:

Behavioral: Routine hospice care

Behavioral: Early palliative care

Routine hospice care for adult

Description:

Being referred to palliative care team when their last chemotherapy is ended among adult participants.

Treatment:

Behavioral: Routine hospice care

Unused palliative care for adult

Description:

haven't been under the palliative care among adult participants

Palliative care for pediatrics

Description:

receiving the palliative care among pediatric participants

Treatment:

Behavioral: Routine hospice care

Behavioral: Early palliative care

Unused palliative care for pediatrics

Description:

haven't received the palliative care among pediatric participants