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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03252678
Enrollment
238
Registered
2017-08-17
Start date
2017-08-17
Completion date
2018-02-28
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Keywords

Advanced Care Planning

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.

Interventions

OTHERa book and videos about ACP

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

OTHERa book and videos about pain control

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

Sponsors

National Institute of Health, Korea
CollaboratorOTHER_GOV
National Clinical Research Coordination Center, Seoul, Korea
CollaboratorOTHER_GOV
Ewha Womans University Mokdong Hospital
CollaboratorOTHER
Ulsan University Hospital
CollaboratorOTHER
Keimyung University Dongsan Medical Center
CollaboratorOTHER
Asan Medical Center
CollaboratorOTHER
Gangneung Asan Hospital
CollaboratorOTHER
Korea University Anam Hospital
CollaboratorOTHER
Daegu Fatima Hospital
CollaboratorOTHER
National Evidence-Based Healthcare Collaborating Agency
CollaboratorOTHER_GOV
Pohang Semyeong Christianity Hospital
CollaboratorUNKNOWN
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Changes in End-of-life Care PreferenceBaseline, within 1 week, 7 weeksComparison the result of End-of-life Care Preference questionnaire

Secondary

MeasureTime frameDescription
Changes in Decision ConflictBaseline, 7 weeksComparison the result of decision conflict questionnaire
Changes in EOL care Discussion and DocumentationBaseline, 7 weeksComparison the result of EOL care Discussion and Documentation questionnaire
Changes in Satisfaction on educational materialsBaseline, 7 weeksComparison Satisfaction on educational materials questionnaire
Changes in Hospital Anxiety and Depression ScaleBaseline, 7 weeksComparison the result of Hospital Anxiety and Depression Scale
Changes in Knowledge of CPRBaseline, 7 weeksComparison the result of knowledge of CPR questionnaire
Intention to document advance care planningBaseline, 7 weeksComparison the result of advance care planning questionnaire
Changes in Decisional Role PreferenceBaseline, 7 weeksComparison the result of decisional role preference questionnaire

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026