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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
144
Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months.
Consultation with PCT physician every 3 weeks.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Change in level of EORTC QLQ-C15-PAL
A questionnaire developed to assess the quality of life of palliative cancer care patients.
Time frame: baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of MQOL
A questionnaire that measures psychological, existential well-being, and support.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in Advance Care Preference
Questions about advance directive and treatment preference in case of terminal condition
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Medical cost and utilization of CAM
Overall medical cost savings (cost effectiveness) and use of complementary and alternative medicine
Time frame: 12 weeks, 24 weeks
1 year survival
1 year survival
Time frame: 1 year
Changes of CQOL
A questionnaire that measures quality of life and burden for family caregivers
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Baseline, 12 weeks, 3 months after death