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Trial record 73 of 73 for:    aromatherapy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03222258
Recruitment Status : Active, not recruiting
First Posted : July 19, 2017
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
National Cancer Center, Korea
Kyunghee University Medical Center
Severance Hospital
Gyeongsang National University Hospital
Chungnam National University Hospital
Chonbuk National University Hospital
Ewha Womans University Mokdong Hospital
Daegu Fatima Hospital
Chonnam National University Hospital
Keimyung University Dongsan Medical Center
Hallym University Medical Center
Asan Medical Center
National Evidence-Based Healthcare Collaborating Agency
National Institute of Health, Korea
National Clinical Research Coordination Center, Seoul, Korea
Ulsan University Hospital
Information provided by (Responsible Party):
Young Ho Yun, Seoul National University Hospital

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.

Condition or disease Intervention/treatment
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 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.


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Study Type : Observational
Actual Enrollment : 444 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 17, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019


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



Primary Outcome Measures :
  1. Change from baseline Overall QOL of EORTC QLQ - Core 15 at 6 months items [ Time Frame: Baseline, 3 months, 6 months ]
    to measure quality of life of adult patients developed by European Organisation for Research and Treatment of Cancer for Palliative Care


Secondary Outcome Measures :
  1. Patients survival and Physicians Orders for Life Sustaining Treatment (POLST) documentation [ Time Frame: Baseline, 3 months, 6 months ]
    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.)

  2. Patient Health Questionnaire-9 [ Time Frame: Baseline, 3 months, 6 months ]
    "Patient Health Questionnaire-9 items" is used as assessment tool to measure depression of both patients and their caregivers by completing the questionnaire.

  3. Decision Conflict Scale [ Time Frame: Baseline, 6 months ]
    "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.

  4. Understanding the illness [ Time Frame: Baseline, 3 months, 6 months ]
    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.

  5. Self-reported Health Status [ Time Frame: Baseline, 3 months, 6 months ]
    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.)

  6. KG-7(The Korean Cancer Study Group Geriatric Score) [ Time Frame: Baseline, 3 months, 6 months ]
    To measure Daily functional skills in elderly only in 65-year or order patients.

  7. Medical cost in KRW/person/month [ Time Frame: 3 months, 6 months ]
    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.

  8. Utilization of healthcare services [ Time Frame: 3 months, 6 months ]
    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.

  9. Preference of Advance care and Palliative care [ Time Frame: 3 months, 6 months ]
    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.

  10. Mcgill Quality of Life (MQOL) [ Time Frame: Baseline, 3 months, 6 months ]
    To measure mental, social, spiritual quality of life of both patients and caregivers

  11. Pediatric Quality of Life Inventory [ Time Frame: Baseline, 3 months, 6 months ]
    "Pediatric Quality of Life Inventory(Peds QL)" will be used as assessment tool for QOL among pediatric patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222258


Locations
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Korea, Republic of
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Gyeongsang National University Hospital
Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, Korea, Republic of, 58128
Daegu Fatima Hospital
Daegu, Korea, Republic of, 41199
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 41931
Chungnam National University Hospital
Daejeon, Korea, Republic of, 35015
Kyunghee University Medical Center
Seoul, Korea, Republic of, 02447
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital
Seoul, Korea, Republic of, 03722
Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 05355
Asan Medical Center
Seoul, Korea, Republic of, 05505
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of, 07985
Ulsan University Hospital
Ulsan, Korea, Republic of, 44033
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
National Cancer Center, Korea
Kyunghee University Medical Center
Severance Hospital
Gyeongsang National University Hospital
Chungnam National University Hospital
Chonbuk National University Hospital
Ewha Womans University Mokdong Hospital
Daegu Fatima Hospital
Chonnam National University Hospital
Keimyung University Dongsan Medical Center
Hallym University Medical Center
Asan Medical Center
National Evidence-Based Healthcare Collaborating Agency
National Institute of Health, Korea
National Clinical Research Coordination Center, Seoul, Korea
Ulsan University Hospital
Investigators
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Principal Investigator: Young Ho Yun, MD-PhD Seoul National University Hospital

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Responsible Party: Young Ho Yun, Clinical Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03222258     History of Changes
Other Study ID Numbers: HC15C1391-2
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Young Ho Yun, Seoul National University Hospital:
Palliative Care
Quality of Life
Prospective Cohort Study
Treatment decision
Utilization of health care

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Liver Neoplasms
Hematologic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Hematologic Diseases