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

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: NCT02489799
Recruitment Status : Completed
First Posted : July 3, 2015
Results First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Advance care planning video Behavioral: Control video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families
Actual Study Start Date : July 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : February 2017

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02489799


Locations
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United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Rebecca A Aslakson, MD PhD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02489799    
Other Study ID Numbers: J1549
IRB00047112 ( Other Identifier: JHMIRB )
First Posted: July 3, 2015    Key Record Dates
Results First Posted: August 29, 2017
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Through mandated reporting by the Patient-Centered Outcomes Research Institute (PCORI), our data will be shared via their website.
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
advance care planning