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

Cancer Clinical Trial

— ACPvideo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489799
• Other study ID #: J1549
• Secondary ID: IRB00047112
• Status: Completed
• Phase: N/A
• First received: July 1, 2015
• Last updated: August 28, 2017
• Start date: July 2015
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured ACP Content in the Presurgical Consent Visit	The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.	Approximately one week after study enrollment.
Primary	Measured Patient Centeredness in the Presurgical Consent Visit	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	Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period	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
Secondary	Iowa Goals of Care Across Study Arms Throughout the Study Period	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
Secondary	Helpfulness of the Video Across Study Arms	This Likert scale evaluates respondent beliefs about the helpfulness of the video.	One week after enrollment
Secondary	Comfort With the Video Across Study Arms	This Likert scale evaluates respondent beliefs about their comfort in viewing the video.	One week after enrollment
Secondary	Recommendation of the Video to Others Across Study Arms	This Likert scale evaluates respondent beliefs about whether they would recommend the video to others.	One week after enrollment
Secondary	Patient and Provider Satisfaction Scores Across Study Arms	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
Secondary	Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period	This tracks which participants report having named a surrogate decision maker	Enrollment, one month after surgery
Secondary	Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period	This tracks which participants report having had an advance care planning-related conversation with their surrogate decision maker.	Enrollment, one month after surgery