Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Media Communication Intervention to Increase Engagement in Advance Care Planning Among Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208009
Recruitment Status : Terminated (Failed to meet recruitment goal and lost study staff due to COVID-19)
First Posted : December 23, 2019
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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).

Condition or disease Intervention/treatment Phase
Advance Care Planning Animated Videos Behavioral: Advance care planning animated videos Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group, open trial design with pre- and post-assessments.
Masking: None (Open Label)
Masking Description: No masking exists due to the single-arm nature of this pilot trial.
Primary Purpose: Supportive Care
Official Title: A Media Communication Intervention to Increase Engagement in Advance Care Planning Among Advanced Cancer Patients
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : March 30, 2021

Arm Intervention/treatment
Experimental: Advance care planning animated videos
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.
Behavioral: Advance care planning animated videos
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208009


Locations
Layout table for location information
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Megan Shen, PhD Weill Medical College of Cornell University
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04208009    
Other Study ID Numbers: 19-04020251
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No