NCT03252678

Brief Summary

This study verifies efficacy of Self-education program for advanced care planning. Half of participants will receive a book and videos about advanced care planning while the other half will receive a book and videos about pain control for cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 17, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

July 13, 2017

Last Update Submit

October 15, 2018

Conditions

Advanced Cancer

Keywords

Advanced Care Planning

Outcome Measures

Primary Outcomes (1)

  • Changes in End-of-life Care Preference

    Comparison the result of End-of-life Care Preference questionnaire

    Baseline, within 1 week, 7 weeks

Secondary Outcomes (7)

  • Changes in Hospital Anxiety and Depression Scale

    Baseline, 7 weeks

  • Changes in Decision Conflict

    Baseline, 7 weeks

  • Changes in EOL care Discussion and Documentation

    Baseline, 7 weeks

  • Changes in Satisfaction on educational materials

    Baseline, 7 weeks

  • Changes in Decisional Role Preference

    Baseline, 7 weeks

  • +2 more secondary outcomes

Study Arms (2)

A Book and Videos about ACP

EXPERIMENTAL

Subjects in experimental group get a book of 45 pages and three videos about advanced care planning based on Smart Management Strategy for Health (SMASH). After they finish reading and watching the materials, they fill out the questionnaire.

Other: a book and videos about ACP

A Book and Videos about Pain Control

ACTIVE COMPARATOR

Subjects in the group get a book and two videos about pain control for cancer patients. After they finish reading and watching the materials, they fill out the questionnaire.

Other: a book and videos about pain control

Interventions

a book and videos about ACPOTHER

A book and three videos about advanced care planning are provided for self-education

A Book and Videos about ACP
a book and videos about pain controlOTHER

A book and three videos about pain control for cancer patients are provided for self-education

A Book and Videos about Pain Control

Eligibility Criteria

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

You may qualify if:

  • Subject 20 years old and more
  • Subject who understands the purpose of the study and signs with informed consent form
  • Subject with advanced cancer
  • Subject who knows he/she is diagnosed with advanced cancer

You may not qualify if:

  • Inability to speak, understand, or write Korean
  • Inability to understand the contents of the provided materials due to poor eyesight and hearing
  • Medical conditions that would limit adherence to participation of the clinical trial (as confirmed by their referring physician; e.g. dyspnea, depression and other mental disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University

Seoul, South Korea

Location

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
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2017

First Posted

August 17, 2017

Study Start

August 17, 2017

Primary Completion

February 21, 2018

Study Completion

February 28, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

KR(1)