Clinical trial NCT03181854: Randomized Controlled Trial of Integrated Early Palliative Care
Official title: Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Solid Tumor
Keywords: Integrated Early Palliative Care
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Evidence-Based Healthcare Collaborating Agency
name: National Institute of Health, Korea
name: National Clinical Research Coordination Center, Seoul, Korea
name: Seoul National University Bundang Hospital
name: Severance Hospital
name: Gyeongsang National University Hospital
name: Chungnam National University Hospital
name: Chonbuk National University Hospital
name: Daegu Fatima Hospital
name: Hallym University Medical Center
name: Korea University Guro Hospital
name: Asan Medical Center
name: Chonnam National University Hospital
name: Ewha Womans University Mokdong Hospital
name: Keimyung University Dongsan Medical Center
name: Ulsan University Hospital
name: Pohang Semyeong Christianity Hospital
name: Gangneung Asan Hospital
First posted: 2017-06-09
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in level of EORTC QLQ-C15-PAL
timeFrame: baseline, 12 weeks, 18 weeks, 24 weeks
Secondary outcomes:
measure: Change in level of MQOL
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in level of EQ-5D of EuroQoL
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in level of PHQ-9
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in level of Understanding the illness
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in level of Crisis Overcoming Capability(SAT-SF)
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in Advance Care Preference
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Medical cost and utilization of CAM
timeFrame: 12 weeks, 24 weeks
measure: 1 year survival
timeFrame: 1 year
measure: Changes of CQOL
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in level of PHQ-9 of family caregivers
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in level of Understanding the illness of family caregivers
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in level of Crisis Overcoming Capability(SAT-SF) of family caregivers
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in Advance Care Preference of family caregivers
timeFrame: Baseline, 12 weeks, 18 weeks, 24 weeks
measure: Change in Quality Care Questionnaire
timeFrame: Baseline, 12 weeks, 3 months after death
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Ho Yun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: