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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The goal of this study is to increase and improve Goals of Care discussions for advanced cancer patients by training medical oncologists to conduct these discussions. The investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of treatment in line with preferences, use of aggressive treatment, and oncologist communication skill.
Among advanced cancer patients, discussions about prognosis, goals of care (GoC) and end-of-life preferences improve quality of life of patients and reduce rates of hospital and ICU admission. Yet, few patients know their chemotherapy treatments will not cure their disease despite nearly all wishing to receive information- good & bad. Currently, 37% of advanced cancer patients have GoC clarifying discussions and when they do, it is often in the last 2 months of life when symptoms are uncontrollable and oncologists have no other treatments to offer. These discussions do not usually happen with the patient's personal oncologist. Current efforts to teach oncologists such skills are impractical, requiring a lot of time away from their office practice and do not take into account job pressures.
The goal of this study is to increase and improve GoC discussions for advanced cancer patients by training medical oncologists to conduct these discussions and evaluate its effects on patient satisfaction, receipt of care in line with preferences, aggressive care utilization, and oncologist communication skill.
The investigators will recruit 280 patients of which half will come from intervention doctors and the other from the control doctors. The investigators will train randomly selected oncologists to conduct GoC discussion. Patients will be surveyed at baseline within days of their GOC visit and at 6 months. Oncologists will be audio-taped at baseline and after training is complete to assess practice and skill to conduct GoC discussions.
Primary outcomes include patient reported conduct of and satisfaction with GoC discussion. Secondary outcomes include oncologist communication skills, feasibility of performing GoC in the outpatient setting, receipt of care in line with preferences, use of hospice, chemotherapy or ICU in the last 30 days of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GoC intervention | Experimental | Oncologists trained using OncoTalk to have Goals of Care discussions. |
|
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GoC intervention | Behavioral | Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Perceived Increased Goals of Care Discussions | Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey. | up to 6 months |
| Number of Patients Perception of Improved Goals of Care Discussions | Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Communication Skills Training | Oncologist's communication skills are tested and rated between 1 and 7, with higher number indicating the oncologists were more comfortable in demonstrating communication skills while having the Goals of Care discussion with their patients. | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Bickell, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital, Yale Cancer Center, Yale University | New Haven | Connecticut | 06510 | United States | ||
Oncologists were not considered enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients - GoC Intervention | Patients given OncoTalk GoC intervention GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction. |
| FG001 | Patients - Usual Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2018 | Jul 30, 2019 |
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|
| Mount Sinai Beth Israel |
| New York |
| New York |
| 10011 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Kings County Hospital Center | New York | New York | 11203 | United States |
Prospective control group where no intervention was given. |
| FG002 | Oncologists - GoC Intervention | Oncologists trained using OncoTalk to have Goals of Care discussions. |
| FG003 | Oncologists - Usual Care | Oncologists not trained using OncoTalk to have Goals of Care discussions. |
| COMPLETED |
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| NOT COMPLETED |
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Data was collected for patient participants only
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients - GoC Intervention | Patients given OncoTalk GoC intervention GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction. |
| BG001 | Patients - Usual Care | Prospective control group where no intervention was given. |
| BG002 | Oncologists - GoC Intervention | Oncologists trained using OncoTalk to have Goals of Care discussions. |
| BG003 | Oncologists - Usual Care | Oncologists not trained using OncoTalk to have Goals of Care discussions. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Participants Who Perceived Increased Goals of Care Discussions | Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey. | Data from patient participants only. Data not collected from Oncologists | Posted | Count of Participants | Participants | up to 6 months |
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| Primary | Number of Patients Perception of Improved Goals of Care Discussions | Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey. | Data collected for patient participants only | Posted | Count of Participants | Participants | up to 6 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Communication Skills Training | Oncologist's communication skills are tested and rated between 1 and 7, with higher number indicating the oncologists were more comfortable in demonstrating communication skills while having the Goals of Care discussion with their patients. | Participants represented are the oncologist's. Data collected for the oncologists only. | Posted | Mean | Standard Deviation | number of skills tested | up to 6 months |
|
Adverse events were not monitored/assessed
Adverse events were not monitored/assessed
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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 | Patients - GoC Intervention | Patients given OncoTalk GoC intervention GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Patients - Usual Care | Prospective control group where no intervention was given. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Oncologists - GoC Intervention | Oncologists trained using OncoTalk to have Goals of Care discussions. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Oncologists - Usual Care | Oncologists not trained using OncoTalk to have Goals of Care discussions. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Radhi Yagnik | Icahn School of Medicine at Mount Sinai | 212-659-5933 | radhi.yagnik@mountsinai.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2015 | Jul 30, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D005909 | Glioblastoma |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D008545 | Melanoma |
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D018358 | Neuroendocrine Tumors |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
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Prospective control group where no intervention was given. |
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