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| Name | Class |
|---|---|
| National Evidence-Based Healthcare Collaborating Agency | OTHER_GOV |
| National Institute of Health, Korea | OTHER_GOV |
| National Clinical Research Coordination Center, Seoul, Korea | OTHER_GOV |
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This study verifies whether integrated Early Palliative Care for advanced cancer patients diagnosed due to a solid tumor improve quality of life and enhances the ability to overcome the current crisis.
Previous reports suggest that starting palliative care early in cancer patients appears to improve patient's quality of life, symptom management, depression, and anxiety.
This study aims to evaluate the effect of the introduction of early palliative care services to advanced cancer patients. Eligible patients are 20 years or older, and has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor, a European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months or less. The primary goal of an integrated early palliative care program is to improve the overall quality of life of patients and their families. Secondarily, it is to help understand the disease, resolving conflicts in the decision-making process, improving the crisis coping capacity, and further determining the patient's and family's advanced care planning. At last, it is desired to evaluate the effect of the program on overall medical cost savings and 1 year survival.
Participants of the study will be allocated in the intervention group and the control group equally. Within three weeks from the time of randomization, the first meeting with a palliative care team will be held. In the time of baseline questionnaire, patients will be provided with self-study education materials and videos on the early palliative care and advance care planning. Once in every three weeks for six months, which is the duration for one treatment course, palliative care for advance care planning, symptom control, and other mental, social and spiritual problems will be provided. After the first meeting with the palliative care team, telephone coaching will be performed once a week for the first 12 weeks and then every two weeks until the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Consultation with PCT doctor every 3 weeks. Telephone coaching once a week for 3 months and once in 2 weeks for another 3 months. |
|
| Control Group | No Intervention | Usual palliative care can be provided if desired. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone coaching | Behavioral | Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in level of EORTC QLQ-C15-PAL | A questionnaire developed to assess the quality of life of palliative cancer care patients. | baseline, 12 weeks, 18 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in level of MQOL | A questionnaire that measures psychological, existential well-being, and support. | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in level of EQ-5D of EuroQoL | A questionnaire that measures mobility, self-care, daily activity, pain/discomfort, and anxiety/depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Ho Yun, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea | ||
| Gyeongsang National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40457290 | Derived | Jung JY, Yun JY, Kang JH, Koh SJ, Kim YJ, Seo S, Kim JH, Cheon J, Kang EJ, Song EK, Nam EM, Oh HS, Choi HJ, Kwon JH, Bae WK, Lee JE, Jung KH, Kang E, Yun YH. Interaction effect of comorbid depression and proactive positivity coping strategy on the 1-year survival of patients with advanced cancer: a nationwide multicentre study in South Korea. BMC Psychiatry. 2025 Jun 2;25(1):565. doi: 10.1186/s12888-025-06972-4. | |
| 39115845 |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Seoul National University Bundang Hospital | OTHER |
| Severance Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Chungnam National University Hospital | OTHER |
| Chonbuk National University Hospital | OTHER |
| Daegu Fatima Hospital | OTHER |
| Hallym University Medical Center | OTHER |
| Korea University Guro Hospital | OTHER |
| Asan Medical Center | OTHER |
| Chonnam National University Hospital | OTHER |
| Ewha Womans University Mokdong Hospital | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| Ulsan University Hospital | OTHER |
| Pohang Semyeong Christianity Hospital | UNKNOWN |
| Gangneung Asan Hospital | OTHER |
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| Consultation with PCT doctor | Behavioral | Consultation with PCT physician every 3 weeks. |
|
| Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in level of PHQ-9 | 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in level of Understanding the illness | 2 questions to assess how patients understand the prognosis of their illness | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in level of Crisis Overcoming Capability(SAT-SF) | A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice. | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in Advance Care Preference | Questions about advance directive and treatment preference in case of terminal condition | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Medical cost and utilization of CAM | Overall medical cost savings (cost effectiveness) and use of complementary and alternative medicine | 12 weeks, 24 weeks |
| 1 year survival | 1 year survival | 1 year |
| Changes of CQOL | A questionnaire that measures quality of life and burden for family caregivers | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in level of PHQ-9 of family caregivers | 9-question instrument given to caregivers in a primary care setting to screen for the presence and severity of depression. | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in level of Understanding the illness of family caregivers | 2 questions to assess how family caregivers understand the prognosis of patients' illness | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in level of Crisis Overcoming Capability(SAT-SF) of family caregivers | A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice of family caregivers. | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in Advance Care Preference of family caregivers | Questions about family caregivers' preference on advance directive and treatment in case of terminal condition | Baseline, 12 weeks, 18 weeks, 24 weeks |
| Change in Quality Care Questionnaire | The 4-factor, 32-item Quality Care Questionnaire-Palliative Care (QCQ-PC), which covers appropriate communication with health care professionals (ten items), discussing value of life and goals of care (nine items), support and counseling for needs of holistic care (seven items), and accessibility and sustainability of care (six items). | Baseline, 12 weeks, 3 months after death |
| Jinju |
| Gyeongsangnam-do |
| 52727 |
| South Korea |
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do | 58128 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Derived |
| Kang E, Kang JH, Koh SJ, Kim YJ, Seo S, Kim JH, Cheon J, Kang EJ, Song EK, Nam EM, Oh HS, Choi HJ, Kwon JH, Bae WK, Lee JE, Jung KH, Yun YH. Early Integrated Palliative Care in Patients With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2426304. doi: 10.1001/jamanetworkopen.2024.26304. |