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Completed

NCT Number: NCT03252678

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

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

a book and videos about ACP

Other

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

a book and videos about pain control

Other

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

Primary outcomes

  1. 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

  1. Changes in Hospital Anxiety and Depression Scale

    Time frame: Baseline, 7 weeks

    Comparison the result of Hospital Anxiety and Depression Scale

  2. Changes in Decision Conflict

    Time frame: Baseline, 7 weeks

    Comparison the result of decision conflict questionnaire

  3. Changes in EOL care Discussion and Documentation

    Time frame: Baseline, 7 weeks

    Comparison the result of EOL care Discussion and Documentation questionnaire

  4. Changes in Satisfaction on educational materials

    Time frame: Baseline, 7 weeks

    Comparison Satisfaction on educational materials questionnaire

  5. Changes in Decisional Role Preference

    Time frame: Baseline, 7 weeks

    Comparison the result of decisional role preference questionnaire

  6. Changes in Knowledge of CPR

    Time frame: Baseline, 7 weeks

    Comparison the result of knowledge of CPR questionnaire

  7. Intention to document advance care planning

    Time frame: Baseline, 7 weeks

    Comparison the result of advance care planning questionnaire

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Asan Medical Center
  • Daegu Fatima Hospital
  • 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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2017
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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