Advance Care Planning Animated VideosNCT04208009
A Media Communication Intervention to Increase Engagement in Advance Care Planning Among Cancer Patients
A study testing Advance care planning animated videos in people with Advance Care Planning Animated Videos, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Advance care planning (ACP) is critical to the provision of quality end-of-life (EoL) care and has been associated with greater likelihood of patients' EoL wishes being followed. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Advance Care Planning Animated Videos
- What is being tested?
- Advance care planning animated videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 30 Mar 2021
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or older
- Diagnosis of cancer
- English fluency
Who cannot join
- Patients who are too weak or cognitively impaired to participate will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: A Media Communication Intervention to Increase Engagement in Advance Care Planning Among Advanced Cancer Patients
Advance care planning (ACP) is critical to the provision of quality end-of-life (EoL) care and has been associated with greater likelihood of patients' EoL wishes being followed. Despite the importance of engaging in ACP, less than half of cancer patients engage in ACP and those with low health literacy are at greatest risk of not completing advance directives. Major limitations of prior work include not effectively improving knowledge of ACP and patients viewing ACP as irrelevant. The proposed studies aim to address these prior limitations by developing and pilot testing empirically grounded, novel, easy-to-understand, and engaging communication tools that apply the medium of animated videos to communicate ACP. Specifically, the proposed studies will develop and pilot-test four animated videos (description of ACP; importance of engaging in ACP now; importance of communicating ACP to loved ones, health care proxies, and providers; and how to communicate wishes and complete advance directives).
Read the detailed description
Engagement in advance care planning (ACP) has been linked across several studies to improving quality of care at the end of life and is a national priority as indicated by the Oncology Care Model requiring completion of advanced directives for all cancer patients. The goal of this Kellen Fellowship Award study is to develop and pilot test a theoretically-grounded, communication-based intervention designed to promote engagement in ACP and improve rates of completion of advance directives [living will, health care proxy (HCP), do-not-resuscitate (DNR) order]. Despite the need for improved knowledge of ACP and engagement in ACP, a 2014 systematic review indicates that only 55% of prior ACP interventions successfully improved knowledge of ACP.5 These findings highlight the need to develop an ACP intervention that communicates ACP in an engaging, easy-to-use format designed to increase knowledge of and engagement in ACP.
The proposed intervention will address these limitations of prior interventions by developing a communication tool designed to engage cancer patients in ACP using a novel, empirically grounded communication tool animated videos. Prior research highlights the use of animated videos more effectively delivering medical information than written instructional materials, which have been traditionally used in previously developed ACP interventions. One prior study using a randomized controlled trial (RCT) found that animated videos were one of the most effective mediums for improving knowledge around patients' informed consent for medical procedures, being significantly higher than the use of text or no materials. Most notably, animated messages have been shown to significantly improve attitudes towards colorectal cancer screening among those with low health literacy as well as recall of information such that participants' recall of information matched those with high health literacy. Patients with low health literacy represent a disadvantaged group in regard to ACP as they have the lowest rates of advance directive completion (12% vs. 49.5% of those with adequate literacy).9 In summary, the use of animated videos to communicate the essential pieces of information around ACP and completion of advance directives holds great promise for improving patient knowledge and engagement in ACP among cancer patients, including those with low health literacy.
In the proposed study, a series of animated videos will be developed which will discuss: 1) what ACP is; 2) why patients should complete ACP now; 3) the importance of communicating wishes to loved ones, health care proxies, and medical team members; and 4) how to communicate these wishes and complete advance directives. These topics were selected based on Dr. Shen's preliminary data and prior research10 highlighting that the greatest barriers to engaging in ACP include: 1) lack of knowledge or awareness, 2) not viewing ACP as relevant to one's current situation, and 3) concerns around designating a health care proxy and communicating one's wishes. This study has three specific aims:
Specific Aim 1: To identify usability and acceptability and obtain feedback for modifications of preliminary animated video content explaining ACP and advance directives using qualitative interviews with cancer patients.
Specific Aim 2: To develop animated videos on specific components of ACP (description of ACP; importance of engaging in ACP now; importance of communicating ACP to loved ones, health care proxies, and providers; and how to communicate wishes and complete advance directives) and evaluate the feasibility, usability, and acceptability of the intervention.
Specific Aim 3: To evaluate patients' perceived ability to use the animated videos and their knowledge of and confidence in completing advance directives after viewing the videos.
First, this study will recruit n=15 patients with solid or liquid tumor cancer from oncology clinics at Weill Cornell Medicine to assess animated videos through initial sketches of content (called storyboards) using semi-structured interviews. Second, this study will develop and finalize the animated videos and field-test the intervention in an open trial among a new sample of cancer patients (n=30) to determine the feasibility, usability, acceptability, and potential efficacy of the intervention. We will assess outcomes at baseline and post-intervention.
- Conditions
- Advance Care Planning Animated Videos
- Being tested
- Advance care planning animated videos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance care planning animated videosBehavioural
Four advance care planning videos: 1) Description of ACP; 2) Explanation of the importance of engaging in ACP now; 3) Communicating wishes to one's loved ones and family members; and 4) Communicating wishes to one's doctor.
| Study group | Role | What they receive |
|---|---|---|
| Advance care planning animated videos | Experimental | This arm consists of viewing four advance care planning videos: 1) Description of ACP; 2) Explanation of the importance of engaging in ACP now; 3) Communicating wishes to one's loved ones and family members; and 4) Communicating wishes to one's doctor. Receives: Behavioral: Advance care planning animated videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the intervention, as measured by the Utility Questionnaire (UQ)
The Utility Questionnaire (UQ) is a 12-item measure using a Likert-scale response format that assesses usability, likeability, usefulness, understandability, and convenience of interventions (0 = not at all, 4 = very). Total scores range from 0 (low) to 48 (high), with higher scores representing higher levels of utility for participants. The UQ has demonstrated strong reliability in previous studies of interventions and has been adapted and used by Dr. Shen to assess usability, likeability, and usefulness of animated video content. This will be assessed separately for each video.
Measured: One week post-intervention
Acceptability of the intervention, as measured by the Acceptability of Self-Guided Treatment Questionnaire (AST)
The Acceptability of Self-Guided Treatment Questionnaire (AST) includes 12 Likert-scale items developed to assess the acceptability of interventions (1 = strongly disagree, 7 = strongly agree). Total scores range from 12 (low) to 84 (high) with higher scores representing higher levels of acceptability. The AST has demonstrated adequate internal consistency in previous studies.34,35 This scale will be asked in reference to ACP and advance directives. This will be assessed separately for each video.
Measured: One week post-intervention
Engagement in advance care planning, as measured by the Measure of Current Status (MOCS)
The Measure of Current Status (MOCS) is a 13-item questionnaire designed to assess cancer patients' self-perceived ability to engage in techniques included in psychological interventions using a Likert-scale response format (0 = I cannot do this at all, 4 = I can do this extremely well). Total scores range from 0 (low) to 52 (high), with higher scores representing higher levels of self-perceived ability. This questionnaire has been previously modified and utilized by Dr. Shen to assess self-perceived ability to engage in ACP and completion of advance directives.
Measured: Baseline and one week post-intervention
Understanding of advance care planning (ACP)
Understanding of ACP will be assessed with true/false items developed to assess understanding of the information presented in the ACP animated videos.
Measured: Baseline and one week post-intervention
Understanding of advance directives
Understanding of advance directives will be assessed with 10 true/false items developed to assess patients' understanding of completing advance directives (DNR orders, HCPs, and living wills). These items are currently being used in an R01-funded study in the WCM Center for Research on End-of-Life Care.
Measured: Baseline and one week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 May 2020
- Primary completion30 Jan 2021
- Study completion30 Mar 2021
Why it stopped: Failed to meet recruitment goal and lost study staff due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care Planning Animated VideosStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open trial design with pre- and post-assessments.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Shen, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208009
- Sponsor's protocol ID
- 19-04020251
- Status last verified
- Apr 2021
- First submitted
- 19 Dec 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Media Communication Intervention to Increase Engagement in Advance Care Planning Among Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT04208009
- Acronym / sponsor ID
- 19-04020251
- Conditions
- Advance Care Planning Animated Videos
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to meet recruitment goal and lost study staff due to COVID-19
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 23 Dec 2019 (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.
Advance care planning (ACP) is critical to the provision of quality end-of-life (EoL) care and has been associated with greater likelihood of patients' EoL wishes being followed. Despite the importance of engaging in ACP, less than half of cancer patients engage in ACP and those with low health literacy are at greatest risk of not completing advance directives. Major limitations of prior work include not effectively improving knowledge of ACP and patients viewing ACP as irrelevant. The proposed studies aim to address these prior limitations by developing and pilot testing empirically grounded, novel, easy-to-understand, and engaging communication tools that apply the medium of animated videos to communicate ACP. Specifically, the proposed studies will develop and pilot-test four animated videos (description of ACP; importance of engaging in ACP now; importance of communicating ACP to loved ones, health care proxies, and providers; and how to communicate wishes and complete advance directives).
Detailed description
Engagement in advance care planning (ACP) has been linked across several studies to improving quality of care at the end of life and is a national priority as indicated by the Oncology Care Model requiring completion of advanced directives for all cancer patients. The goal of this Kellen Fellowship Award study is to develop and pilot test a theoretically-grounded, communication-based intervention designed to promote engagement in ACP and improve rates of completion of advance directives [living will, health care proxy (HCP), do-not-resuscitate (DNR) order]. Despite the need for improved knowledge of ACP and engagement in ACP, a 2014 systematic review indicates that only 55% of prior ACP interventions successfully improved knowledge of ACP.5 These findings highlight the need to develop an ACP intervention that communicates ACP in an engaging, easy-to-use format designed to increase knowledge of and engagement in ACP.
The proposed intervention will address these limitations of prior interventions by developing a communication tool designed to engage cancer patients in ACP using a novel, empirically grounded communication tool animated videos. Prior research highlights the use of animated videos more effectively delivering medical information than written instructional materials, which have been traditionally used in previously developed ACP interventions. One prior study using a randomized controlled trial (RCT) found that animated videos were one of the most effective mediums for improving knowledge around patients' informed consent for medical procedures, being significantly higher than the use of text or no materials. Most notably, animated messages have been shown to significantly improve attitudes towards colorectal cancer screening among those with low health literacy as well as recall of information such that participants' recall of information matched those with high health literacy. Patients with low health literacy represent a disadvantaged group in regard to ACP as they have the lowest rates of advance directive completion (12% vs. 49.5% of those with adequate literacy).9 In summary, the use of animated videos to communicate the essential pieces of information around ACP and completion of advance directives holds great promise for improving patient knowledge and engagement in ACP among cancer patients, including those with low health literacy.
In the proposed study, a series of animated videos will be developed which will discuss: 1) what ACP is; 2) why patients should complete ACP now; 3) the importance of communicating wishes to loved ones, health care proxies, and medical team members; and 4) how to communicate these wishes and complete advance directives. These topics were selected based on Dr. Shen's preliminary data and prior research10 highlighting that the greatest barriers to engaging in ACP include: 1) lack of knowledge or awareness, 2) not viewing ACP as relevant to one's current situation, and 3) concerns around designating a health care proxy and communicating one's wishes. This study has three specific aims:
Specific Aim 1: To identify usability and acceptability and obtain feedback for modifications of preliminary animated video content explaining ACP and advance directives using qualitative interviews with cancer patients.
Specific Aim 2: To develop animated videos on specific components of ACP (description of ACP; importance of engaging in ACP now; importance of communicating ACP to loved ones, health care proxies, and providers; and how to communicate wishes and complete advance directives) and evaluate the feasibility, usability, and acceptability of the intervention.
Specific Aim 3: To evaluate patients' perceived ability to use the animated videos and their knowledge of and confidence in completing advance directives after viewing the videos.
First, this study will recruit n=15 patients with solid or liquid tumor cancer from oncology clinics at Weill Cornell Medicine to assess animated videos through initial sketches of content (called storyboards) using semi-structured interviews. Second, this study will develop and finalize the animated videos and field-test the intervention in an open trial among a new sample of cancer patients (n=30) to determine the feasibility, usability, acceptability, and potential efficacy of the intervention. We will assess outcomes at baseline and post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open trial design with pre- and post-assessments.
| Arm | Type | Receives |
|---|---|---|
| Advance care planning animated videos | Experimental | Behavioral: Advance care planning animated videosThis arm consists of viewing four advance care planning videos: 1) Description of ACP; 2) Explanation of the importance of engaging in ACP now; 3) Communicating wishes to one's loved ones and family members; and 4) Communicating wishes to one's doctor. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 years or older
- Diagnosis of cancer
- English fluency
Key exclusion criteria (1 listed)
- Patients who are too weak or cognitively impaired to participate will be excluded.
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 |
|---|---|---|
| Advance care planning animated videosFour advance care planning videos: 1) Description of ACP; 2) Explanation of the importance of engaging in ACP now; 3) Communicating wishes to one's loved ones and family members; and 4) Communicating wishes to one's doctor. | Behavioural | Advance care planning animated videos |
Primary outcome
Usability of the intervention, as measured by the Utility Questionnaire (UQ)
Time frame: One week post-intervention
The Utility Questionnaire (UQ) is a 12-item measure using a Likert-scale response format that assesses usability, likeability, usefulness, understandability, and convenience of interventions (0 = not at all, 4 = very). Total scores range from 0 (low) to 48 (high), with higher scores representing higher levels of utility for participants. The UQ has demonstrated strong reliability in previous studies of interventions and has been adapted and used by Dr. Shen to assess usability, likeability, and usefulness of animated video content. This will be assessed separately for each video.
Acceptability of the intervention, as measured by the Acceptability of Self-Guided Treatment Questionnaire (AST)
Time frame: One week post-intervention
The Acceptability of Self-Guided Treatment Questionnaire (AST) includes 12 Likert-scale items developed to assess the acceptability of interventions (1 = strongly disagree, 7 = strongly agree). Total scores range from 12 (low) to 84 (high) with higher scores representing higher levels of acceptability. The AST has demonstrated adequate internal consistency in previous studies.34,35 This scale will be asked in reference to ACP and advance directives. This will be assessed separately for each video.
Engagement in advance care planning, as measured by the Measure of Current Status (MOCS)
Time frame: Baseline and one week post-intervention
The Measure of Current Status (MOCS) is a 13-item questionnaire designed to assess cancer patients' self-perceived ability to engage in techniques included in psychological interventions using a Likert-scale response format (0 = I cannot do this at all, 4 = I can do this extremely well). Total scores range from 0 (low) to 52 (high), with higher scores representing higher levels of self-perceived ability. This questionnaire has been previously modified and utilized by Dr. Shen to assess self-perceived ability to engage in ACP and completion of advance directives.
Understanding of advance care planning (ACP)
Time frame: Baseline and one week post-intervention
Understanding of ACP will be assessed with true/false items developed to assess understanding of the information presented in the ACP animated videos.
Understanding of advance directives
Time frame: Baseline and one week post-intervention
Understanding of advance directives will be assessed with 10 true/false items developed to assess patients' understanding of completing advance directives (DNR orders, HCPs, and living wills). These items are currently being used in an R01-funded study in the WCM Center for Research on End-of-Life Care.
Results and safety
The study was stopped early (reason given: Failed to meet recruitment goal and lost study staff due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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.
Megan Shen, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance care planning animated videos in people with Advance Care Planning Animated Videos, run by Weill Medical College of Cornell University at 1 site in United States.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Apr 2021. 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 United States. 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 was stopped early (reason given: Failed to meet recruitment goal and lost study staff due to COVID-19). Results are not available in the source record.
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?
Usability of the intervention, as measured by the Utility Questionnaire (UQ) (time frame: One week post-intervention). The study lists 5 primary outcomes in all. 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 20 Apr 2021.