Trial Outcomes & Findings for Engagement of Patients With Advanced Cancer (NCT NCT02966509)

Last Updated: 2018-10-31

Results Overview

Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.

Recruitment status

COMPLETED

Study phase

Target enrollment

213 participants

Primary outcome timeframe

6 months after each patient enrollment

Results posted on

2018-10-31

Participant Flow

August 2013 recruitment for overall study through new patient visit screening, phone calls to patients prior to first oncology appointment, and referral by physicians when diagnosed with recurrent cancers. Recruitment completed in February 2015.

Participant milestones

Participant milestones
Measure	A: Intervention Arm All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm All participants randomized to Arm B will receive usual oncologic care.
Baseline Satisfaction Survey STARTED	105	108
Baseline Satisfaction Survey COMPLETED	101	101
Baseline Satisfaction Survey NOT COMPLETED	4	7
6 Month Satisfaction Decision Survey STARTED	105	108
6 Month Satisfaction Decision Survey COMPLETED	80	77
6 Month Satisfaction Decision Survey NOT COMPLETED	25	31
6 Month Satisfaction Survey STARTED	105	108
6 Month Satisfaction Survey COMPLETED	58	60
6 Month Satisfaction Survey NOT COMPLETED	47	48
6-Month Utilization and Cost STARTED	105	108
6-Month Utilization and Cost COMPLETED	105	108
6-Month Utilization and Cost NOT COMPLETED	0	0
15-Month Utilization and Cost STARTED	105	108
15-Month Utilization and Cost COMPLETED	105	108
15-Month Utilization and Cost NOT COMPLETED	0	0
End of Life Utilization and Cost 6 Month STARTED	105	108
End of Life Utilization and Cost 6 Month COMPLETED	36	33
End of Life Utilization and Cost 6 Month NOT COMPLETED	69	75
End of Life Utilization and Cost 15month STARTED	105	108
End of Life Utilization and Cost 15month COMPLETED	60	60
End of Life Utilization and Cost 15month NOT COMPLETED	45	48

Reasons for withdrawal

Reasons for withdrawal
Measure	A: Intervention Arm All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm All participants randomized to Arm B will receive usual oncologic care.
Baseline Satisfaction Survey Withdrawal by Subject	2	3
Baseline Satisfaction Survey Death	0	1
Baseline Satisfaction Survey Lost to Follow-up	1	1
Baseline Satisfaction Survey Refused to Answer	1	2
6 Month Satisfaction Decision Survey Death	22	25
6 Month Satisfaction Decision Survey Withdrawal by Subject	2	3
6 Month Satisfaction Decision Survey Lost to Follow-up	1	1
6 Month Satisfaction Decision Survey Refused to Answer	0	2
6 Month Satisfaction Survey Death	36	33
6 Month Satisfaction Survey Withdrawal by Subject	2	3
6 Month Satisfaction Survey Lost to Follow-up	1	1
6 Month Satisfaction Survey Refused to Answer	8	11
End of Life Utilization and Cost 6 Month Patient Still Alive	69	75
End of Life Utilization and Cost 15month Patient Still Alive	45	48

Baseline Characteristics

Engagement of Patients With Advanced Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.	Total n=213 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=99 Participants	36 Participants n=107 Participants	63 Participants n=206 Participants
Age, Categorical >=65 years	78 Participants n=99 Participants	72 Participants n=107 Participants	150 Participants n=206 Participants
Age, Continuous	69.2 years STANDARD_DEVIATION 9.20 • n=99 Participants	69.4 years STANDARD_DEVIATION 9.05 • n=107 Participants	69.3 years STANDARD_DEVIATION 9.10 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Male	103 Participants n=99 Participants	108 Participants n=107 Participants	211 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=99 Participants	97 Participants n=107 Participants	196 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	9 Participants n=107 Participants	13 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) White	82 Participants n=99 Participants	83 Participants n=107 Participants	165 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	9 Participants n=107 Participants	13 Participants n=206 Participants
Region of Enrollment United States	105 participants n=99 Participants	108 participants n=107 Participants	213 participants n=206 Participants
Cancer Diagnosis Thoracic	41 Participants n=99 Participants	39 Participants n=107 Participants	80 Participants n=206 Participants
Cancer Diagnosis Gastrointestinal	26 Participants n=99 Participants	27 Participants n=107 Participants	53 Participants n=206 Participants
Cancer Diagnosis Genitourinary	8 Participants n=99 Participants	9 Participants n=107 Participants	17 Participants n=206 Participants
Cancer Diagnosis Head and Neck	16 Participants n=99 Participants	15 Participants n=107 Participants	31 Participants n=206 Participants
Cancer Diagnosis Skin	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Cancer Diagnosis Other	7 Participants n=99 Participants	11 Participants n=107 Participants	18 Participants n=206 Participants
Cancer Stage at Diagnosis I	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Cancer Stage at Diagnosis II	12 Participants n=99 Participants	17 Participants n=107 Participants	29 Participants n=206 Participants
Cancer Stage at Diagnosis III	30 Participants n=99 Participants	29 Participants n=107 Participants	59 Participants n=206 Participants
Cancer Stage at Diagnosis IV	59 Participants n=99 Participants	59 Participants n=107 Participants	118 Participants n=206 Participants
Marital Status Married	35 Participants n=99 Participants	40 Participants n=107 Participants	75 Participants n=206 Participants
Marital Status Unmarried	70 Participants n=99 Participants	68 Participants n=107 Participants	138 Participants n=206 Participants
Total Baseline Health Care Costs	14052 US Dollars n=99 Participants	11455 US Dollars n=107 Participants	13090 US Dollars n=206 Participants

PRIMARY outcome

Timeframe: 6 months after each patient enrollment

Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.
Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.	98 Participants	26 Participants

SECONDARY outcome

Timeframe: 6 months after patient enrollment

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.
Emergency Department Visit (Chart Review)	0.74 visits Standard Deviation 1.12	0.78 visits Standard Deviation 1.15

SECONDARY outcome

Timeframe: 15 months after patient enrollment

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.
Emergency Department Visit (Chart Review)	1.03 Visits Standard Deviation 1.40	1.20 Visits Standard Deviation 1.53

SECONDARY outcome

Timeframe: 6 months after patient enrollment

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.
Hospitalization Visits (Chart Review)	0.62 Visits Standard Deviation 0.80	0.56 Visits Standard Deviation 0.89

SECONDARY outcome

Timeframe: 15 months after patient enrollment

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.
Hospitalization Visits (Chart Review)	0.75 Visits Standard Deviation 0.94	0.88 Visits Standard Deviation 1.07

SECONDARY outcome

Timeframe: 6 months after patient enrollment

Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.
Hospice Referral (Chart Review)	32 Participants	16 Participants

SECONDARY outcome

Timeframe: 6 months after patient enrollment

Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.
Palliative Care Referral (Chart Review)	31 Participants	24 Participants

SECONDARY outcome

Timeframe: 15 months after patient enrollment

Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=105 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=108 Participants All participants randomized to Arm B will receive usual oncologic care.
Palliative Care Referral (Chart Review)	31 Participants	23 Participants

SECONDARY outcome

Timeframe: Change in Patient Satisfaction with Care from baseline to 6 months.

Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=58 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=60 Participants All participants randomized to Arm B will receive usual oncologic care.
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey	-0.54 units on a scale Standard Deviation 2.40	-0.99 units on a scale Standard Deviation 2.40

SECONDARY outcome

Timeframe: 6 months

Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.

Outcome measures

Outcome measures
Measure	A: Intervention Arm n=80 Participants All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.	B: Control Group Arm n=77 Participants All participants randomized to Arm B will receive usual oncologic care.
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey	4.73 units on a scale Standard Deviation 0.61	4.15 units on a scale Standard Deviation 1.02

Adverse Events

A: Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B: Control Group Arm

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

Dr. Manali Patel

Stanford University and VA Palo Alto Health Care System

Phone: 650-723-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place