Randomized Controlled Trial of Integrated Early Palliative Care

August 5, 2019 updated by: Young Ho Yun, Seoul National University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University MokDong Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Gyeongsangnam-do
      • Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Chonbuk National University Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 12 weeks, 18 weeks, 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in level of MQOL
Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks
A questionnaire that measures psychological, existential well-being, and support.
Baseline, 12 weeks, 18 weeks, 24 weeks
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.
Baseline, 12 weeks, 18 weeks, 24 weeks
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.
Baseline, 12 weeks, 18 weeks, 24 weeks
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
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
A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice.
Baseline, 12 weeks, 18 weeks, 24 weeks
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
Baseline, 12 weeks, 18 weeks, 24 weeks
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
12 weeks, 24 weeks
1 year survival
Time Frame: 1 year
1 year survival
1 year
Changes of CQOL
Time Frame: Baseline, 12 weeks, 18 weeks, 24 weeks
A questionnaire that measures quality of life and burden for family caregivers
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
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
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
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
A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice of family caregivers.
Baseline, 12 weeks, 18 weeks, 24 weeks
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
Baseline, 12 weeks, 18 weeks, 24 weeks
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).
Baseline, 12 weeks, 3 months after death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chonbuk National University Hospital
Asan Medical Center
Chonnam National University Hospital
Ulsan University Hospital
Seoul National University Bundang Hospital
Korea University Guro Hospital
Gyeongsang National University Hospital
Severance Hospital
Ewha Womans University Mokdong Hospital
Keimyung University Dongsan Medical Center
Hallym University Medical Center
Chungnam National University Hospital
National Evidence-Based Healthcare Collaborating Agency
National Clinical Research Coordination Center, Seoul, Korea
National Institute of Health, Korea
Gangneung Asan Hospital
Daegu Fatima Hospital
Pohang Semyeong Christianity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HC15C1391-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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