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Completed

NCT Number: NCT03181854

Randomized Controlled Trial of Integrated Early Palliative Care

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.

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Key information

Conditions

Advanced Cancer Solid Tumor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone coaching

Behavioral

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

Behavioral

Consultation with PCT physician every 3 weeks.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 9, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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