Trial Outcomes & Findings for Improving Goals of Care Discussion in Advanced Cancer Patients (NCT NCT02374255)

NCT ID: NCT02374255

Last Updated: 2019-10-01

Results Overview

Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 265 participants
• Primary outcome timeframe: up to 6 months
• Results posted on: 2019-10-01

Participant Flow

Oncologists were not considered enrolled into the study.

Participant milestones

Measure	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.	Patients - Usual Care Prospective control group where no intervention was given.	Oncologists - GoC Intervention Oncologists trained using OncoTalk to have Goals of Care discussions.	Oncologists - Usual Care Oncologists not trained using OncoTalk to have Goals of Care discussions.
Overall Study STARTED	155	110	11	11
Overall Study COMPLETED	153	110	11	11
Overall Study NOT COMPLETED	2	0	0	0

Reasons for withdrawal

Measure	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.	Patients - Usual Care Prospective control group where no intervention was given.	Oncologists - GoC Intervention Oncologists trained using OncoTalk to have Goals of Care discussions.	Oncologists - Usual Care Oncologists not trained using OncoTalk to have Goals of Care discussions.
Overall Study Withdrawal by Subject	2	0	0	0

Baseline Characteristics

Improving Goals of Care Discussion in Advanced Cancer Patients

Baseline characteristics by cohort

Measure	Patients - GoC Intervention n=155 Participants Patients given OncoTalk GoC intervention GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.	Patients - Usual Care n=110 Participants Prospective control group where no intervention was given.	Oncologists - GoC Intervention Oncologists trained using OncoTalk to have Goals of Care discussions.	Oncologists - Usual Care Oncologists not trained using OncoTalk to have Goals of Care discussions.	Total n=265 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 12.3 • n=5 Participants	65 years STANDARD_DEVIATION 11.3 • n=7 Participants	—	—	64 years STANDARD_DEVIATION 11.8 • n=21 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	44 Participants n=7 Participants	—	—	108 Participants n=21 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	66 Participants n=7 Participants	—	—	157 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	21 Participants n=7 Participants	—	—	50 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	126 Participants n=5 Participants	89 Participants n=7 Participants	—	—	215 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	3 Participants n=7 Participants	—	—	11 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	50 Participants n=5 Participants	29 Participants n=7 Participants	—	—	79 Participants n=21 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	65 Participants n=7 Participants	—	—	136 Participants n=21 Participants
Race (NIH/OMB) More than one race	26 Participants n=5 Participants	13 Participants n=7 Participants	—	—	39 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: Data from patient participants only. Data not collected from Oncologists

Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.

Outcome measures

Measure	Patients - GoC Intervention n=153 Participants Patients given OncoTalk GoC intervention GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.	Patients - Usual Care n=110 Participants Prospective control group where no intervention was given.	Oncologist - GoC Intervention Oncologists trained using OncoTalk to have Goals of Care discussions.	Oncologists - Usual Care Oncologists not trained using OncoTalk to have Goals of Care discussions.
Number of Participants Who Perceived Increased Goals of Care Discussions	43 Participants	34 Participants	—	—

PRIMARY outcome

Timeframe: up to 6 months

Population: Data collected for patient participants only

Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey.

Outcome measures

Measure	Patients - GoC Intervention n=153 Participants Patients given OncoTalk GoC intervention GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.	Patients - Usual Care n=110 Participants Prospective control group where no intervention was given.	Oncologist - GoC Intervention Oncologists trained using OncoTalk to have Goals of Care discussions.	Oncologists - Usual Care Oncologists not trained using OncoTalk to have Goals of Care discussions.
Number of Patients Perception of Improved Goals of Care Discussions	70 Participants	65 Participants	—	—

SECONDARY outcome

Timeframe: up to 6 months

Population: Participants represented are the oncologist's. Data collected for the oncologists only.

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.

Outcome measures

Measure	Patients - GoC Intervention n=11 Participants Patients given OncoTalk GoC intervention GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.	Patients - Usual Care n=11 Participants Prospective control group where no intervention was given.	Oncologist - GoC Intervention Oncologists trained using OncoTalk to have Goals of Care discussions.	Oncologists - Usual Care Oncologists not trained using OncoTalk to have Goals of Care discussions.
Communication Skills Training	3.7 number of skills tested Standard Deviation 1.96	2.2 number of skills tested Standard Deviation 1.08	—	—

Adverse Events

Patients - GoC Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients - Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oncologists - GoC Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oncologists - Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Radhi Yagnik

Icahn School of Medicine at Mount Sinai

Phone: 212-659-5933

Email: radhi.yagnik@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place