Efficacy of Self-education Program for Advanced Care Planning(RCT)

NCT ID: NCT03252678

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-17

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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This study validates effectiveness of educational materials that the investigators developed due to the rates of completing advanced care planning are considerably low and patients relatively less less preferred to receive palliative care and hospice at terminal status, which is led by the lack of information available to patients; whether these decision aids change end-of-life care preference, elevate the preference of patients toward advanced care planning, reduce the burden of decision making compare to educational resources that are currently available.

Previous studies inform that educational video about advanced care planning increases the knowledge of care for life prolongation, and affects the preference towards care for life prolongation and palliative care. However, being no resources are provided and orally explained, patients in the control group don't have enough time to fully aware of the information, also, since those studies are done mostly in the western countries, 'discussing with family members or guardians' part is missing, which is critical under contemporary Korean medical society. This study provides educational resources to both the intervention group and the control group and identifies if advanced care planning is discussed with family members or guardians.

Primary outcome of this study is end-of-life care preference. Participants of this study will fill out the baseline questionnaire about end-of-life care preference, end-of-life discussion and documentation, knowledge of ACP, etc. After that, participants will be allocated equally into the intervention group and the control group. The intervention group will receive a book and videos about advanced care planning which are based on Smart Management Strategy for Health(SMASH). The control group will receive a book and videos about pain control for cancer patients that were provided by Korea National Cancer Center. After reading and watching the educational materials, patients will get another questionnaire about knowledge of ACP, satisfaction on the materials, end-of-life care preference, and decision role preference. Participants will read and watch the materials for about 6-8 weeks and then they will be asked to complete another questionnaire which includes every questions from the baseline and post-intervention. The result from all three questionnaires (baseline, post-intervention, 7-week questionnaire) will be compiled and be compared with one another.

Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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A Book and Videos about ACP

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.

Group Type EXPERIMENTAL

a book and videos about ACP

Intervention Type OTHER

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

A Book and Videos about Pain Control

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.

Group Type ACTIVE_COMPARATOR

a book and videos about pain control

Intervention Type OTHER

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

Interventions

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a book and videos about ACP

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

Intervention Type OTHER

a book and videos about pain control

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Health, Korea

OTHER_GOV

Sponsor Role collaborator

National Clinical Research Coordination Center, Seoul, Korea

OTHER_GOV

Sponsor Role collaborator

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role collaborator

Ulsan University Hospital

OTHER

Sponsor Role collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role collaborator

Gangneung Asan Hospital

OTHER

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role collaborator

Daegu Fatima Hospital

OTHER

Sponsor Role collaborator

National Evidence-Based Healthcare Collaborating Agency

OTHER_GOV

Sponsor Role collaborator

Pohang Semyeong Christianity Hospital

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Ho Yun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Ho Yun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HC15C1391-3

Identifier Type: -

Identifier Source: org_study_id

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