NCT03181854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 8, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

June 7, 2017

Last Update Submit

August 5, 2019

Conditions

Advanced CancerSolid Tumor

Keywords

Integrated Early Palliative Care

Outcome Measures

Primary Outcomes (1)

  • Change in level of EORTC QLQ-C15-PAL

    A questionnaire developed to assess the quality of life of palliative cancer care patients.

    baseline, 12 weeks, 18 weeks, 24 weeks

Secondary Outcomes (14)

  • Change in level of MQOL

    Baseline, 12 weeks, 18 weeks, 24 weeks

  • Change in level of EQ-5D of EuroQoL

    Baseline, 12 weeks, 18 weeks, 24 weeks

  • Change in level of PHQ-9

    Baseline, 12 weeks, 18 weeks, 24 weeks

  • Change in level of Understanding the illness

    Baseline, 12 weeks, 18 weeks, 24 weeks

  • Change in level of Crisis Overcoming Capability(SAT-SF)

    Baseline, 12 weeks, 18 weeks, 24 weeks

  • +9 more secondary outcomes

Study Arms (2)

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.

Behavioral: Telephone coachingBehavioral: Consultation with PCT doctor

Control Group

NO INTERVENTION

Usual palliative care can be provided if desired.

Interventions

Telephone coachingBEHAVIORAL

Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months.

Intervention group
Consultation with PCT doctorBEHAVIORAL

Consultation with PCT physician every 3 weeks.

Intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 52727, South Korea

Location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Related Publications (2)

  • Jung 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.

    PMID: 40457290DERIVED

  • Kang 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.

    PMID: 39115845DERIVED

MeSH Terms

Interventions

Referral and Consultation

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Young Ho Yun, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 9, 2017

Study Start

September 8, 2017

Primary Completion

October 24, 2018

Study Completion

June 30, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

KR(10)