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Randomized Controlled Trial of Integrated Early Palliative Care

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ClinicalTrials.gov Identifier: NCT03181854
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : October 12, 2018
Sponsor:
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
Information provided by (Responsible Party):
Young Ho Yun, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Solid Tumor Behavioral: Telephone coaching Behavioral: Consultation with PCT doctor Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Intervention group
Consultation with PCT doctor every 3 weeks. Telephone coaching once a week for 3 months and once in 2 weeks for another 3 months.
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.

Behavioral: Consultation with PCT doctor
Consultation with PCT physician every 3 weeks.

No Intervention: Control Group
Usual palliative care can be provided if desired.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in level of MQOL [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    A questionnaire that measures psychological, existential well-being, and support.

  2. Change in level of EQ-5D of EuroQoL [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    A questionnaire that measures mobility, self-care, daily activity, pain/discomfort, and anxiety/depression.

  3. Change in level of PHQ-9 [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression.

  4. Change in level of Understanding the illness [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    2 questions to assess how patients understand the prognosis of their illness

  5. Change in level of Crisis Overcoming Capability(SAT-SF) [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice.

  6. Change in Advance Care Preference [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    Questions about advance directive and treatment preference in case of terminal condition

  7. Medical cost and utilization of CAM [ Time Frame: 12 weeks, 24 weeks ]
    Overall medical cost savings (cost effectiveness) and use of complementary and alternative medicine

  8. 1 year survival [ Time Frame: 1 year ]
    1 year survival

  9. Changes of CQOL [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    A questionnaire that measures quality of life and burden for family caregivers

  10. Change in level of PHQ-9 of family caregivers [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    9-question instrument given to caregivers in a primary care setting to screen for the presence and severity of depression.

  11. Change in level of Understanding the illness of family caregivers [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    2 questions to assess how family caregivers understand the prognosis of patients' illness

  12. Change in level of Crisis Overcoming Capability(SAT-SF) of family caregivers [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice of family caregivers.

  13. Change in Advance Care Preference of family caregivers [ Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks ]
    Questions about family caregivers' preference on advance directive and treatment in case of terminal condition

  14. Change in Quality Care Questionnaire [ Time Frame: Baseline, 12 weeks, 3 months after death ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181854


Contacts
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Contact: Eunkyo Kang, MD 82-2-740-8417 ekherb@naver.com
Contact: Jiyeon Choo 82-2-740-8437 greatlight1247@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Yoo Jung Kim         
Gyeongsang National University Hospital Recruiting
Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
Contact: Jung Hun Kang         
Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Contact: Eun Ki Song, MD, PhD         
Sub-Investigator: Na-Ri Lee, MD, MS         
Chonnam National University Hwasun Hospital Active, not recruiting
Hwasun, Jeollanam-do, Korea, Republic of, 58128
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
Contact: Hwan Jung Yun, MD, PhD         
Seoul National University Hospital Active, not recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital Active, not recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of, 05505
Ewha Womans University Mokdong Hospital Active, not recruiting
Seoul, Korea, Republic of, 07985
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 44033
Contact: Su-jin Koh, MD,PhD         
Sponsors and Collaborators
Seoul National University Hospital
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
Investigators
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Principal Investigator: Young Ho Yun, MD, PhD Seoul National University Hospital

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Responsible Party: Young Ho Yun, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03181854     History of Changes
Other Study ID Numbers: HC15C1391-1
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Young Ho Yun, Seoul National University Hospital:
Integrated Early Palliative Care