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

NCT02489799 | Completed Results DMC

• 2 other identifiers: J1549IRB00047112
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

advance care planning

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (8)

• Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period

  Enrollment, one week after enrollment, one week after surgery, one month after surgery

• Iowa Goals of Care Across Study Arms Throughout the Study Period

  Enrollment, one week after enrollment, one week after surgery, one month after surgery

• Helpfulness of the Video Across Study Arms

  One week after enrollment

• Comfort With the Video Across Study Arms

  One week after enrollment

• Recommendation of the Video to Others Across Study Arms

  One week after enrollment

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Advance care planning video

Behavioral: Advance care planning video

Control

PLACEBO COMPARATOR

Control video - no advance care planning content

Behavioral: Control video

Interventions

Advance care planning video BEHAVIORAL

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.

Intervention

Control video BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• Aslakson RA, Isenberg SR, Crossnohere NL, Conca-Cheng AM, Moore M, Bhamidipati A, Mora S, Miller J, Singh S, Swoboda SM, Pawlik TM, Weiss M, Volandes A, Smith TJ, Bridges JFP, Roter DL. Integrating Advance Care Planning Videos into Surgical Oncologic Care: A Randomized Clinical Trial. J Palliat Med. 2019 Jul;22(7):764-772. doi: 10.1089/jpm.2018.0209. Epub 2019 Apr 9.

  PMID: 30964385 DERIVED

• Isenberg SR, Crossnohere NL, Patel MI, Conca-Cheng A, Bridges JFP, Swoboda SM, Smith TJ, Pawlik TM, Weiss M, Volandes AE, Schuster A, Miller JA, Pastorini C, Roter DL, Aslakson RA. An advance care plan decision support video before major surgery: a patient- and family-centred approach. BMJ Support Palliat Care. 2018 Jun;8(2):229-236. doi: 10.1136/bmjspcare-2017-001449. Epub 2018 Mar 18.

  PMID: 29555812 DERIVED

• Aslakson RA, Isenberg SR, Crossnohere NL, Conca-Cheng AM, Yang T, Weiss M, Volandes AE, Bridges JFP, Roter DL. Utilising advance care planning videos to empower perioperative cancer patients and families: a study protocol of a randomised controlled trial. BMJ Open. 2017 Jun 6;7(5):e016257. doi: 10.1136/bmjopen-2017-016257.

  PMID: 28592584 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Rebecca Aslakson, M.D., Ph.D.
• Organization: The Johns Hopkins University School of Medicine

raslaks1@jhmi.edu

410-955-9082

Study Officials

• Rebecca A Aslakson, MD PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 3, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2017
• Last Updated: August 29, 2017
• Results First Posted: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)