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
Verified date | March 2021 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
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 |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01987726 -
Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
|
||
Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
Terminated |
NCT01918306 -
GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01705340 -
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
|
Phase 1 | |
Terminated |
NCT01222377 -
Endoscopic Breast Surgery in Treating Patients With Breast Cancer
|
N/A | |
Completed |
NCT00602043 -
F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer
|
Phase 2 | |
Completed |
NCT00425672 -
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
|
Phase 1/Phase 2 | |
Completed |
NCT00096109 -
Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT00100750 -
Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00244881 -
A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)
|
Phase 2 | |
Completed |
NCT00096434 -
Sorafenib in Treating Patients With Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT00057941 -
Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT02892734 -
Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer
|
Phase 2 | |
Recruiting |
NCT03213041 -
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT02015559 -
Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus
|
Phase 2 | |
Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
Completed |
NCT03364348 -
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
|
Phase 1 | |
Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01672684 -
Phase I: At-Home Support for Rural Women Using Group Video Calling
|
Phase 1 | |
Terminated |
NCT01149356 -
RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer
|
Phase 1 |