Clinical trial NCT02489799: Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families
Official title: Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: advance care planning
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-07-03
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Measured ACP Content in the Presurgical Consent Visit
timeFrame: Approximately one week after study enrollment.
measure: Measured Patient Centeredness in the Presurgical Consent Visit
timeFrame: Approximately one week after study enrollment.
Secondary outcomes:
measure: Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period
timeFrame: Enrollment, one week after enrollment, one week after surgery, one month after surgery
measure: Iowa Goals of Care Across Study Arms Throughout the Study Period
timeFrame: Enrollment, one week after enrollment, one week after surgery, one month after surgery
measure: Helpfulness of the Video Across Study Arms
timeFrame: One week after enrollment
measure: Comfort With the Video Across Study Arms
timeFrame: One week after enrollment
measure: Recommendation of the Video to Others Across Study Arms
timeFrame: One week after enrollment
measure: Patient and Provider Satisfaction Scores Across Study Arms
timeFrame: One week after enrollment
measure: Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period
timeFrame: Enrollment, one month after surgery
measure: Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period
timeFrame: Enrollment, one month after surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Rebecca A Aslakson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.