Advanced CancerNCT03181854
Randomized Controlled Trial of Integrated Early Palliative Care
A study testing Telephone coaching and Consultation with PCT doctor in people with Advanced Cancer and Solid Tumor, run by Seoul National University Hospital at 10 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Cancer, Solid Tumor
- What is being tested?
- Telephone coaching and Consultation with PCT doctor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 8 Sep 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Chungnam National University Hospital
Daejeon, 35015
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Ewha Womans University Mokdong Hospital
Seoul, 07985
Ulsan University Hospital
Ulsan, 44033
About this study
Official title: Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients
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.
Read the 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.
- Conditions
- Advanced Cancer, Solid Tumor
- Being tested
- Telephone coaching, Consultation with PCT doctor
- Keywords
- Integrated Early Palliative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone coachingBehavioural
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 doctorBehavioural
Consultation with PCT physician every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telephone coaching; Behavioral: Consultation with PCT doctor |
| Control Group | No intervention | Usual palliative care can be provided if desired. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of EORTC QLQ-C15-PAL
A questionnaire developed to assess the quality of life of palliative cancer care patients.
Measured: baseline, 12 weeks, 18 weeks, 24 weeks
Secondary outcomes (14)
Change in level of MQOL
A questionnaire that measures psychological, existential well-being, and support.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in Advance Care Preference
Questions about advance directive and treatment preference in case of terminal condition
Measured: 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
Measured: 12 weeks, 24 weeks
1 year survival
1 year survival
Measured: 1 year
Changes of CQOL
A questionnaire that measures quality of life and burden for family caregivers
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: Baseline, 12 weeks, 3 months after death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start8 Sep 2017
- Primary completion24 Oct 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Seoul National University Bundang Hospital, Severance Hospital, Gyeongsang National University Hospital, Chungnam National University Hospital, Chonbuk National University Hospital, Daegu Fatima Hospital, Hallym University Medical Center, Korea University Guro Hospital, Asan Medical Center, Chonnam National University Hospital, Ewha Womans University Mokdong Hospital, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Pohang Semyeong Christianity Hospital, Gangneung Asan Hospital
- Responsible party
- Principal investigator, Young Ho Yun, Seoul National University Hospital
- Investigators
- Young Ho Yun, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181854
- Sponsor's protocol ID
- HC15C1391-1
- Status last verified
- Aug 2019
- First submitted
- 7 Jun 2017
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang E, Koh SJ, Kang JH, 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. Quality Matters: Effect of High-Quality Early Palliative Care in Advanced Cancer. J Pain Symptom Manage. 2025 Dec;70(6):638-648. doi: 10.1016/j.jpainsymman.2025.08.031. Epub 2025 Sep 2.
PubMed 40907620Jung 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.
PubMed 40457290Kang 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.
PubMed 39115845
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT03181854
- Acronym / sponsor ID
- HC15C1391-1
- Conditions
- Advanced Cancer, Solid Tumor
- Keywords
- Integrated Early Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Seoul National University Bundang Hospital, Severance Hospital, Gyeongsang National University Hospital, Chungnam National University Hospital, Chonbuk National University Hospital, Daegu Fatima Hospital, Hallym University Medical Center, Korea University Guro Hospital, Asan Medical Center, Chonnam National University Hospital, Ewha Womans University Mokdong Hospital, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Pohang Semyeong Christianity Hospital, Gangneung Asan Hospital
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Telephone coaching, Behavioral: Consultation with PCT doctorConsultation 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone coachingTelephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months. | Behavioural | Intervention group |
| Consultation with PCT doctorConsultation with PCT physician every 3 weeks. | Behavioural | Intervention group |
Primary outcome
Change in level of EORTC QLQ-C15-PAL
Time frame: baseline, 12 weeks, 18 weeks, 24 weeks
A questionnaire developed to assess the quality of life of palliative cancer care patients.
14 secondary outcomes
Change in level of MQOL
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of EQ-5D of EuroQoL
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of PHQ-9
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of Understanding the illness
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of Crisis Overcoming Capability(SAT-SF)
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in Advance Care Preference
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Medical cost and utilization of CAM
Time frame: 12 weeks, 24 weeks
1 year survival
Time frame: 1 year
Changes of CQOL
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of PHQ-9 of family caregivers
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of Understanding the illness of family caregivers
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of Crisis Overcoming Capability(SAT-SF) of family caregivers
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in Advance Care Preference of family caregivers
Time frame: Baseline, 12 weeks, 18 weeks, 24 weeks
Change in Quality Care Questionnaire
Time frame: Baseline, 12 weeks, 3 months after death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 40907620Kang E, Koh SJ, Kang JH, 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. Quality Matters: Effect of High-Quality Early Palliative Care in Advanced Cancer. J Pain Symptom Manage. 2025 Dec;70(6):638-648. doi: 10.1016/j.jpainsymman.2025.08.031. Epub 2025 Sep 2.
- Derived from this study: PubMed 40457290Jung 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.
- Derived from this study: PubMed 39115845Kang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Ho Yun, MD, PhD principal investigator
Seoul National University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone coaching and Consultation with PCT doctor in people with Advanced Cancer and Solid Tumor, run by Seoul National University Hospital at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of EORTC QLQ-C15-PAL (time frame: baseline, 12 weeks, 18 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03181854, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.