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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00047112 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Advance care planning video |
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| Control | Placebo Comparator | Control video - no advance care planning content |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca A Aslakson, MD PhD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30964385 | Derived | 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. | |
| 29555812 |
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Through mandated reporting by the Patient-Centered Outcomes Research Institute (PCORI), our data will be shared via their website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Advance care planning video 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. |
| FG001 | Control | Control video - no advance care planning content 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Advance care planning video 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measured ACP Content in the Presurgical Consent Visit | The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content. | Of note, the sample size is smaller for this outcome as our study did not collect recordings for all participants enrolled at the baseline visit. The reasons we did not collect the recordings include scheduling of emergent surgery without time to record, human and technology error, and patient preference. | Posted | Count of Units | Recordings | Approximately one week after study enrollment. | Recordings | Recordings |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Advance care planning video 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Aslakson, M.D., Ph.D. | The Johns Hopkins University School of Medicine | 410-955-9082 | raslaks1@jhmi.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| 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. |
|
| 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. | 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. | One week after enrollment |
| Comfort With the Video Across Study Arms | This Likert scale evaluates respondent beliefs about their comfort in viewing the video. | 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. | 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. | 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 | 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. | Enrollment, one month after surgery |
| 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. |
| 28592584 | 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. |
| Withdrawal by Subject |
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| Death |
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| BG001 | Control | Control video - no advance care planning content 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Primary Diagnosis | Count of Participants | Participants |
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| OG001 | Control | Control video - no advance care planning content 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. |
|
|
| 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. | Audio recordings of a presurgical consent visit conversation between a surgeon and patient. | Posted | Mean | Standard Deviation | Patient Centeredness Score | Approximately one week after study enrollment. | Audio Recordings | Audio Recordings |
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|
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| 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). | At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility. | Posted | Mean | Standard Deviation | units on a scale | Enrollment, one week after enrollment, one week after surgery, one month after surgery |
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|
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| 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. | At each milestone of data collection, a number of participants were unable to complete the Iowa Goals of Care questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility. | Posted | Count of Participants | Participants | Enrollment, one week after enrollment, one week after surgery, one month after surgery |
|
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| Secondary | Helpfulness of the Video Across Study Arms | This Likert scale evaluates respondent beliefs about the helpfulness of the video. | Posted | Count of Participants | Participants | One week after enrollment |
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| Secondary | Comfort With the Video Across Study Arms | This Likert scale evaluates respondent beliefs about their comfort in viewing the video. | Posted | Count of Participants | Participants | One week after enrollment |
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| 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. | Posted | Count of Participants | Participants | One week after enrollment |
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| 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. | In two instances, the surgeon was unable to complete the satisfaction scale. This explains why there are fewer surgeon perceptions reported than patients. | Posted | Mean | Standard Deviation | units on a scale | One week after enrollment |
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| 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 | At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility. | Posted | Count of Participants | Participants | Enrollment, one month after surgery |
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| 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. | This question was only asked to participants who reported having designated a medical decision maker. | Posted | Count of Participants | Participants | Enrollment, one month after surgery |
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| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Control | Control video - no advance care planning content 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. | 0 | 47 | 0 | 47 |
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| Equivalence |
The study was powered based on two former studies utilizing RIAS, (both powered =.8 and alpha =.05). With a 0.6 effect size, the required sample size is 72 patients (36 per group) for a one-tailed test of study hypotheses (power =.8 and alpha =.05). |
| Presurgical Consent Visit (V2) |
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| Postsurgical One Week Visit (V3) |
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| Postsurgical One Month Visit (V4) |
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| Presurgical Consent Visit (V2) |
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| Postsurgical One Week Visit (V3) |
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| Postsurgical One Month Visit (V4) |
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| A Little Helpful |
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| Not Helpful |
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| Somewhat Uncomfortable |
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| Very Uncomfortable |
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| Probably Would Not Recommend |
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| Definitely Would Not Recommend |
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| Surgeon Self-Reported Satisfaction |
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| Have Identified a Medical Decision Maker |
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| Postsurgical One Month Visit (V4) |
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| Yes, over 6 months ago |
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| Yes, within the last 6 months |
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| Postsurgical One Month Visit (V4) |
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