Randomized Controlled Trial of Integrated Early Palliative Care

Solid Tumor Clinical Trial

Official title:

Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181854
• Other study ID #: HC15C1391-1
• Status: Completed
• Phase: N/A
• Start date: September 8, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 30, 2019
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subject 20 years and older.

• Subject who has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor

• Subject whose ECOG performance status is between 0 to 2.

• Subject with an estimated life expectancy of 12 months and less (assessed by the treating oncologist)

• Subject who volunteers

Exclusion Criteria:

• Inability to speak, understand or write Korean.

• Medical conditions that would limit adherence to participation of the clinical trial(as confirmed by their referring physician; e.g. dyspnea)

• Suspension of all cancer treatment

• Palliative care consultation at any time or in palliative care

Related Conditions & MeSH terms

• Advanced Cancer
• Solid Tumor

Intervention

Behavioral:
• Telephone coaching
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 doctor
Consultation with PCT physician every 3 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon
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	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (19)

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, Gangneung Asan Hospital, Gyeongsang National University Hospital, Hallym University Medical Center, Keimyung University Dongsan Medical Center, Korea University Guro Hospital, National Clinical Research Coordination Center, Seoul, Korea, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, Pohang Semyeong Christianity Hospital, Seoul National University Bundang Hospital, Severance Hospital, Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change in level of MQOL	A questionnaire that measures psychological, existential well-being, and support.	Baseline, 12 weeks, 18 weeks, 24 weeks
Secondary	Change in level of EQ-5D of EuroQoL	A questionnaire that measures mobility, self-care, daily activity, pain/discomfort, and anxiety/depression.	Baseline, 12 weeks, 18 weeks, 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Advance Care Preference	Questions about advance directive and treatment preference in case of terminal condition	Baseline, 12 weeks, 18 weeks, 24 weeks
Secondary	Medical cost and utilization of CAM	Overall medical cost savings (cost effectiveness) and use of complementary and alternative medicine	12 weeks, 24 weeks
Secondary	1 year survival	1 year survival	1 year
Secondary	Changes of CQOL	A questionnaire that measures quality of life and burden for family caregivers	Baseline, 12 weeks, 18 weeks, 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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