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Clinical Trials/NCT03252678
NCT03252678CompletedNot Applicable

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

Seoul National University Hospital1 site in 1 country238 target enrollmentStarted: August 17, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
238
Locations
1
Primary Endpoint
Changes in End-of-life Care Preference

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

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.

Intervention: a book and videos about ACP (Other)

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.

Intervention: a book and videos about pain control (Other)

Outcomes

Primary Outcomes

Changes in End-of-life Care Preference

Time Frame: Baseline, within 1 week, 7 weeks

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

Secondary Outcomes

  • Intention to document advance care planning(Baseline, 7 weeks)
  • Changes in Satisfaction on educational materials(Baseline, 7 weeks)
  • Changes in Decisional Role Preference(Baseline, 7 weeks)
  • Changes in Decision Conflict(Baseline, 7 weeks)
  • Changes in EOL care Discussion and Documentation(Baseline, 7 weeks)
  • Changes in Hospital Anxiety and Depression Scale(Baseline, 7 weeks)
  • Changes in Knowledge of CPR(Baseline, 7 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Young Ho Yun

Principal Investigator

Seoul National University Hospital

Study Sites (1)

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