Clinical trial NCT04208009: A Media Communication Intervention to Increase Engagement in Advance Care Planning Among Cancer Patients
Official title: A Media Communication Intervention to Increase Engagement in Advance Care Planning Among Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Advance Care Planning Animated Videos
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, open trial design with pre- and post-assessments.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age 21 years or older
* Diagnosis of cancer
* English fluency

Exclusion Criteria:

* Patients who are too weak or cognitively impaired to participate will be excluded.

Primary outcomes:
measure: Usability of the intervention, as measured by the Utility Questionnaire (UQ)
timeFrame: One week post-intervention
measure: Acceptability of the intervention, as measured by the Acceptability of Self-Guided Treatment Questionnaire (AST)
timeFrame: One week post-intervention
measure: Engagement in advance care planning, as measured by the Measure of Current Status (MOCS)
timeFrame: Baseline and one week post-intervention
measure: Understanding of advance care planning (ACP)
timeFrame: Baseline and one week post-intervention
measure: Understanding of advance directives
timeFrame: Baseline and one week post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Megan Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: