Cancer of Pancreas, Cancer of Stomach, Colorectal Cancer, Esophageal, Glioblastoma, Head or Neck Cancer, Lung Cancers, Melanoma, Pancreatic Cancers, Primary Stage IV Hepatobiliary, Stage III, Stage IV
Conditions
Keywords
Advanced cancer, goals of care, quality of care, end of life discussions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALGoC intervention
Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.
Sponsors
Patient-Centered Outcomes Research Institute
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women who are at least 21 years of age who have been diagnosed within one month with a pathologically confirmed advanced cancer who have an average of \<2 y life expectancy (primary stage IV hepatobiliary, esophageal, colorectal, glioblastoma, gastric, pancreatic, melanoma, head & neck, or stage III or IV lung or pancreatic cancers) and are being treated at one of the participating hospital sites and speak English or Spanish. * Oncologists who treat at least 2 advanced cancer patients per month at a study participating hospital will be enrolled into the study.
Exclusion criteria
* Patients who have seen an oncologist after undergoing first line treatment imaging as this group has a higher likelihood of having received a goals of care discussion. * Men or women who do not speak English or Spanish will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Perceived Increased Goals of Care Discussions | up to 6 months | Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey. |
| Number of Patients Perception of Improved Goals of Care Discussions | up to 6 months | Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Communication Skills Training | up to 6 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Oncologists were not considered enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 155 |
| Patients - Usual Care Prospective control group where no intervention was given. | 110 |
| Oncologists - GoC Intervention Oncologists trained using OncoTalk to have Goals of Care discussions. | 0 |
| Oncologists - Usual Care Oncologists not trained using OncoTalk to have Goals of Care discussions. | 0 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Patients - Usual Care | Total | Patients - GoC Intervention |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 11.3 | 64 years STANDARD_DEVIATION 11.8 | 63 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 50 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants | 215 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 11 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 79 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 39 Participants | 26 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 65 Participants | 136 Participants | 71 Participants |
| Sex: Female, Male Female | 44 Participants | 108 Participants | 64 Participants |
| Sex: Female, Male Male | 66 Participants | 157 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: up to 6 months
Population: Data from patient participants only. Data not collected from Oncologists
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients - GoC Intervention | Number of Participants Who Perceived Increased Goals of Care Discussions | 43 Participants |
| Patients - Usual Care | Number of Participants Who Perceived Increased Goals of Care Discussions | 34 Participants |
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.
Time frame: up to 6 months
Population: Data collected for patient participants only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients - GoC Intervention | Number of Patients Perception of Improved Goals of Care Discussions | 70 Participants |
| Patients - Usual Care | Number of Patients Perception of Improved Goals of Care Discussions | 65 Participants |
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.
Time frame: up to 6 months
Population: Participants represented are the oncologist's. Data collected for the oncologists only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients - GoC Intervention | Communication Skills Training | 3.7 number of skills tested | Standard Deviation 1.96 |
| Patients - Usual Care | Communication Skills Training | 2.2 number of skills tested | Standard Deviation 1.08 |