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

Efficacy of Self-education Program for Advanced Care Planning: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: a book and videos about ACP; Other: a book and videos about pain control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University

Participation Criteria

Eligibility Criteria

• 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 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: a book and videos about ACP; A book and three videos about advanced care planning are provided for self-education
ACTIVE_COMPARATOR: 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.	Other: a book and videos about pain control; A book and three videos about pain control for cancer patients are provided for self-education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in End-of-life Care Preference	Comparison the result of End-of-life Care Preference questionnaire	Baseline, within 1 week, 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Hospital Anxiety and Depression Scale	Comparison the result of Hospital Anxiety and Depression Scale	Baseline, 7 weeks
Changes in Decision Conflict	Comparison the result of decision conflict questionnaire	Baseline, 7 weeks
Changes in EOL care Discussion and Documentation	Comparison the result of EOL care Discussion and Documentation questionnaire	Baseline, 7 weeks
Changes in Satisfaction on educational materials	Comparison Satisfaction on educational materials questionnaire	Baseline, 7 weeks
Changes in Decisional Role Preference	Comparison the result of decisional role preference questionnaire	Baseline, 7 weeks
Changes in Knowledge of CPR	Comparison the result of knowledge of CPR questionnaire	Baseline, 7 weeks
Intention to document advance care planning	Comparison the result of advance care planning questionnaire	Baseline, 7 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Asan Medical Center; Ulsan University Hospital; Korea University Anam Hospital; Ewha Womans University Mokdong Hospital; Keimyung University Dongsan Medical Center; 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

Study Major Dates

• Study Start (ACTUAL): August 17, 2017
• Primary Completion (ACTUAL): February 21, 2018
• Study Completion (ACTUAL): February 28, 2018

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (ACTUAL): August 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Advanced Care Planning
• Other Study ID Numbers: HC15C1391-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No