Clinical trial NCT03252678: Efficacy of Self-education Program for Advanced Care Planning(RCT)
Official title: Efficacy of Self-education Program for Advanced Care Planning: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: Advanced Care Planning
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Health, Korea
name: National Clinical Research Coordination Center, Seoul, Korea
name: Ewha Womans University Mokdong Hospital
name: Ulsan University Hospital
name: Keimyung University Dongsan Medical Center
name: Asan Medical Center
name: Gangneung Asan Hospital
name: Korea University Anam Hospital
name: Daegu Fatima Hospital
name: National Evidence-Based Healthcare Collaborating Agency
name: Pohang Semyeong Christianity Hospital
First posted: 2017-08-17
Enrollment: 238
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in End-of-life Care Preference
timeFrame: Baseline, within 1 week, 7 weeks
Secondary outcomes:
measure: Changes in Hospital Anxiety and Depression Scale
timeFrame: Baseline, 7 weeks
measure: Changes in Decision Conflict
timeFrame: Baseline, 7 weeks
measure: Changes in EOL care Discussion and Documentation
timeFrame: Baseline, 7 weeks
measure: Changes in Satisfaction on educational materials
timeFrame: Baseline, 7 weeks
measure: Changes in Decisional Role Preference
timeFrame: Baseline, 7 weeks
measure: Changes in Knowledge of CPR
timeFrame: Baseline, 7 weeks
measure: Intention to document advance care planning
timeFrame: Baseline, 7 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
affiliation: Seoul National University Hospital
name: Young Ho Yun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: