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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252678
• Other study ID #: HC15C1391-3
• Status: Completed
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: October 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: February 28, 2018
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Other:
• a book and videos about ACP
A book and three videos about advanced care planning are provided for self-education
• a book and videos about pain control
A book and three videos about pain control for cancer patients are provided for self-education

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University	Seoul

Sponsors (12)

Lead Sponsor

Collaborator

Seoul National University Hospital

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in End-of-life Care Preference	Comparison the result of End-of-life Care Preference questionnaire	Baseline, within 1 week, 7 weeks
Secondary	Changes in Hospital Anxiety and Depression Scale	Comparison the result of Hospital Anxiety and Depression Scale	Baseline, 7 weeks
Secondary	Changes in Decision Conflict	Comparison the result of decision conflict questionnaire	Baseline, 7 weeks
Secondary	Changes in EOL care Discussion and Documentation	Comparison the result of EOL care Discussion and Documentation questionnaire	Baseline, 7 weeks
Secondary	Changes in Satisfaction on educational materials	Comparison Satisfaction on educational materials questionnaire	Baseline, 7 weeks
Secondary	Changes in Decisional Role Preference	Comparison the result of decisional role preference questionnaire	Baseline, 7 weeks
Secondary	Changes in Knowledge of CPR	Comparison the result of knowledge of CPR questionnaire	Baseline, 7 weeks
Secondary	Intention to document advance care planning	Comparison the result of advance care planning questionnaire	Baseline, 7 weeks