Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families (ACPvideo)

August 28, 2017 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Through close engagement with our patient and family member co-investigators, the investigators have developed a video-based advance care planning aid for cancer patients and their family members who are preparing for major surgery. In this study, patients are randomized to see either the intervention video (involving advance care planning-related content) or a control video (no advance care planning-related content) prior to surgery. The investigators hypothesize that the video will lead to more and better preoperative discussions between the patient and surgeon that are related to advance care planning. The investigators also hypothesize that seeing the advance care planning-related video will decrease perioperative anxiety and depression scores.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Many cancer patients pursue aggressive surgery in the hope of cancer cure or life prolongation. However, in doing so, patients and families may avoid advance care planning; they do not discuss specific goals and wishes should disease progress despite surgery. Moreover, a subset of patients become critically ill following surgery, and family members must make life-and-death decisions without knowing patient wishes. Preoperative advance care planning-facilitating patient and family discussions concerning perioperative goals, hopes, and fears-could empower patients and families to better choose which therapies and procedures they want outside of the initial surgery and for the months following surgery. Advance care planning aids exist, but none were developed for or evaluated in a surgical patient population. Furthermore, video-based advance care planning tools are an innovative way to better empower patients and families. Previous research shows that, with the aid of an advance care planning video, patients and families are more knowledgeable about treatment options and more comfortable with making decisions. Moreover, when better educated, these patients and families frequently choose less aggressive therapies.

However, video-based advance care planning tools have not been developed or tested in a surgical patient population. The investigators have developed and now will evaluate a video-based advance care planning aid for cancer patients and families pursing aggressive surgical cancer treatment. The investigators hypothesize that, in patients and family members, the video-based decision aid will facilitate better preoperative discussions about advance care planning between the patient and surgeon and decrease anxiety and depression after surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 and older of study surgeons who are scheduled to have a surgical procedure identified by study surgeons to the study team.
  • Patients willing to give informed consent, ability to speak English, reasonably able to read a newspaper or book (without sight impairment); reasonable able to listen to radio, television (without hearing impairment).

Exclusion Criteria:

  • Age <18 years old, non-English speaking patients who are not identified by participating surgeons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention
Advance care planning video
Behavioral: Advance care planning video
This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
Placebo Comparator: Control
Control video - no advance care planning content
Behavioral: Control video
This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measured ACP Content in the Presurgical Consent Visit
Time Frame: Approximately one week after study enrollment.
The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.
Approximately one week after study enrollment.
Measured Patient Centeredness in the Presurgical Consent Visit
Time Frame: Approximately one week after study enrollment.
The RIAS scoring system using an audio-recording of a conversation to evaluate the nature of the conversation between surgeon and patient. The patient-centeredness summary score is a ratio of statements that reflect the psychosocial and socio-emotional elements of exchange about the lived illness experience of patients relative to statements that reflect a more biomedical and disease focused perspective. This score reflects the encounter as a whole, rather than an individual's dialogue. A value greater than one indicates a more patient-centered encounter; whereas, a value less than one indicates a more biomedical encounter.
Approximately one week after study enrollment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period
Time Frame: Enrollment, one week after enrollment, one week after surgery, one month after surgery
This validated metric consists of two sub scales: one for symptoms of anxiety, and the other for symptoms of depression. Each subscale, consisting of seven questions, results in a score ranging from 0, indicating no distress, to 21, indicating maximum distress; a score higher than 7 indicates clinically meaningful anxiety or depression. Overall HADS scores, encompassing both subscales, results in a total score of 0 (no mood symptoms ) to 42 (maximal mood symptoms).
Enrollment, one week after enrollment, one week after surgery, one month after surgery
Iowa Goals of Care Across Study Arms Throughout the Study Period
Time Frame: Enrollment, one week after enrollment, one week after surgery, one month after surgery
This metric enables respondents to verify why they are seeking medical care. The most selected goal at all visits was "Cure my medical condition." We have reported the number of participants in each group who selected this goal at each time point.
Enrollment, one week after enrollment, one week after surgery, one month after surgery
Helpfulness of the Video Across Study Arms
Time Frame: One week after enrollment
This Likert scale evaluates respondent beliefs about the helpfulness of the video.
One week after enrollment
Comfort With the Video Across Study Arms
Time Frame: One week after enrollment
This Likert scale evaluates respondent beliefs about their comfort in viewing the video.
One week after enrollment
Recommendation of the Video to Others Across Study Arms
Time Frame: One week after enrollment
This Likert scale evaluates respondent beliefs about whether they would recommend the video to others.
One week after enrollment
Patient and Provider Satisfaction Scores Across Study Arms
Time Frame: One week after enrollment
The satisfaction score, as the sum of the scores of six questions (all in Likert scale), ranges from 6 to 30, with a higher score indicating higher level of satisfaction.
One week after enrollment
Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period
Time Frame: Enrollment, one month after surgery
This tracks which participants report having named a surrogate decision maker
Enrollment, one month after surgery
Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period
Time Frame: Enrollment, one month after surgery
This tracks which participants report having had an advance care planning-related conversation with their surrogate decision maker.
Enrollment, one month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca A Aslakson, MD PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • J1549
  • IRB00047112 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Through mandated reporting by the Patient-Centered Outcomes Research Institute (PCORI), our data will be shared via their website.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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