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

NCT ID: NCT02489799

Last Updated: 2017-08-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Advance care planning video

Group Type ACTIVE_COMPARATOR

Advance care planning video

Intervention Type 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.

Control

Control video - no advance care planning content

Group Type PLACEBO_COMPARATOR

Control video

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca A Aslakson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30964385 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29555812 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28592584 (View on PubMed)

Other Identifiers

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IRB00047112

Identifier Type: OTHER

Identifier Source: secondary_id

J1549

Identifier Type: -

Identifier Source: org_study_id

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