CancerACPvideoNCT02489799
Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families
A study testing Advance care planning video in people with Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Advance care planning video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Age <18 years old, non-English speaking patients who are not identified by participating surgeons
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Advance care planning video, Control video
- Keywords
- advance care planning
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance care planning videoBehavioural
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 videoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Advance care planning video Receives: Behavioral: Advance care planning video |
| Control | Placebo comparator | Control video - no advance care planning content Receives: Behavioral: Control video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured ACP Content in the Presurgical Consent Visit
The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.
Measured: 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.
Measured: Approximately one week after study enrollment.
Secondary outcomes (8)
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).
Measured: Enrollment, one week after enrollment, one week after surgery, one month after surgery
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.
Measured: Enrollment, one week after enrollment, one week after surgery, one month after surgery
Helpfulness of the Video Across Study Arms
This Likert scale evaluates respondent beliefs about the helpfulness of the video.
Measured: One week after enrollment
Comfort With the Video Across Study Arms
This Likert scale evaluates respondent beliefs about their comfort in viewing the video.
Measured: One week after enrollment
Recommendation of the Video to Others Across Study Arms
This Likert scale evaluates respondent beliefs about whether they would recommend the video to others.
Measured: One week after enrollment
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.
Measured: One week after enrollment
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
Measured: Enrollment, one month after surgery
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.
Measured: Enrollment, one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Rebecca A Aslakson, MD PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489799
- Sponsor's protocol ID
- J1549
- Other IDs
- IRB00047112
- Acronym
- ACPvideo
- Status last verified
- Aug 2017
- First submitted
- 1 Jul 2015
- Last updated
- 29 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Through mandated reporting by the Patient-Centered Outcomes Research Institute (PCORI), our data will be shared via their website.
Publications
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.
PubMed 30964385Isenberg 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.
PubMed 29555812Aslakson 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.
PubMed 28592584
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families
- ClinicalTrials.gov ID
- NCT02489799
- Acronym / sponsor ID
- ACPvideo / J1549
- Conditions
- Cancer
- Keywords
- advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Posted 29 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Advance care planning videoAdvance care planning video |
| Control | Placebo comparator | Behavioral: Control videoControl video - no advance care planning content |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Age <18 years old, non-English speaking patients who are not identified by participating surgeons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance care planning videoThis 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. | Behavioural | Intervention |
| Control videoThis 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. | Behavioural | Control |
Primary outcome
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.
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.
8 secondary outcomes
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
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
Helpfulness of the Video Across Study Arms
Time frame: One week after enrollment
Comfort With the Video Across Study Arms
Time frame: One week after enrollment
Recommendation of the Video to Others Across Study Arms
Time frame: One week after enrollment
Patient and Provider Satisfaction Scores Across Study Arms
Time frame: One week after enrollment
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30964385Aslakson 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.
- Derived from this study: PubMed 29555812Isenberg 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.
- Derived from this study: PubMed 28592584Aslakson 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.
- Individual participant dataSharing planned: Yes. Through mandated reporting by the Patient-Centered Outcomes Research Institute (PCORI), our data will be shared via their website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca A Aslakson, MD PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance care planning video in people with Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured ACP Content in the Presurgical Consent Visit (time frame: Approximately one week after study enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02489799, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.