Advanced CancerNCT03252678
Efficacy of Self-education Program for Advanced Care Planning(RCT)
A study testing a book and videos about ACP in people with Advanced Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- a book and videos about ACP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Self-education Program for Advanced Care Planning: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- a book and videos about ACP, a book and videos about pain control
- Keywords
- Advanced Care Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a book and videos about ACPOther
A book and three videos about advanced care planning are provided for self-education
a book and videos about pain controlOther
A book and three videos about pain control for cancer patients are provided for self-education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: a book and videos about ACP |
| 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. Receives: Other: a book and videos about pain control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in End-of-life Care Preference
Comparison the result of End-of-life Care Preference questionnaire
Measured: Baseline, within 1 week, 7 weeks
Secondary outcomes (7)
Changes in Hospital Anxiety and Depression Scale
Comparison the result of Hospital Anxiety and Depression Scale
Measured: Baseline, 7 weeks
Changes in Decision Conflict
Comparison the result of decision conflict questionnaire
Measured: Baseline, 7 weeks
Changes in EOL care Discussion and Documentation
Comparison the result of EOL care Discussion and Documentation questionnaire
Measured: Baseline, 7 weeks
Changes in Satisfaction on educational materials
Comparison Satisfaction on educational materials questionnaire
Measured: Baseline, 7 weeks
Changes in Decisional Role Preference
Comparison the result of decisional role preference questionnaire
Measured: Baseline, 7 weeks
Changes in Knowledge of CPR
Comparison the result of knowledge of CPR questionnaire
Measured: Baseline, 7 weeks
Intention to document advance care planning
Comparison the result of advance care planning questionnaire
Measured: Baseline, 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start17 Aug 2017
- Primary completion21 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Ewha Womans University Mokdong Hospital, Ulsan University Hospital, Keimyung University Dongsan Medical Center, Asan Medical Center, Gangneung Asan Hospital, Korea University Anam Hospital, Daegu Fatima Hospital, National Evidence-Based Healthcare Collaborating Agency, Pohang Semyeong Christianity Hospital
- Responsible party
- Principal investigator, Young Ho Yun, Seoul National University Hospital
- Investigators
- Young Ho Yun, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252678
- Sponsor's protocol ID
- HC15C1391-3
- Status last verified
- Oct 2018
- First submitted
- 13 Jul 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self-education Program for Advanced Care Planning: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03252678
- Acronym / sponsor ID
- HC15C1391-3
- Conditions
- Advanced Cancer
- Keywords
- Advanced Care Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Ewha Womans University Mokdong Hospital, Ulsan University Hospital, Keimyung University Dongsan Medical Center, Asan Medical Center, Gangneung Asan Hospital, Korea University Anam Hospital, Daegu Fatima Hospital, National Evidence-Based Healthcare Collaborating Agency, Pohang Semyeong Christianity Hospital
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Book and Videos about ACP | Experimental | Other: a book and videos about ACPSubjects 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. |
| A Book and Videos about Pain Control | Active comparator | Other: a book and videos about pain controlSubjects 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a book and videos about ACPA book and three videos about advanced care planning are provided for self-education | Other | A Book and Videos about ACP |
| a book and videos about pain controlA book and three videos about pain control for cancer patients are provided for self-education | Other | A Book and Videos about Pain Control |
Primary outcome
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
7 secondary outcomes
Changes in Hospital Anxiety and Depression Scale
Time frame: Baseline, 7 weeks
Changes in Decision Conflict
Time frame: Baseline, 7 weeks
Changes in EOL care Discussion and Documentation
Time frame: Baseline, 7 weeks
Changes in Satisfaction on educational materials
Time frame: Baseline, 7 weeks
Changes in Decisional Role Preference
Time frame: Baseline, 7 weeks
Changes in Knowledge of CPR
Time frame: Baseline, 7 weeks
Intention to document advance care planning
Time frame: Baseline, 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Ho Yun, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a book and videos about ACP in people with Advanced Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in End-of-life Care Preference (time frame: Baseline, within 1 week, 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018; AzTrials last refreshed its copy on 4 Nov 2026.