Trial Outcomes & Findings for Engagement of Patients With Advanced Cancer (NCT NCT02966509)
NCT ID: 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
NA
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
| 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
| 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
| 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=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
150 Participants
n=27 Participants
|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 9.20 • n=93 Participants
|
69.4 years
STANDARD_DEVIATION 9.05 • n=4 Participants
|
69.3 years
STANDARD_DEVIATION 9.10 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
211 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
196 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
165 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=93 Participants
|
108 participants
n=4 Participants
|
213 participants
n=27 Participants
|
|
Cancer Diagnosis
Thoracic
|
41 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Cancer Diagnosis
Gastrointestinal
|
26 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Cancer Diagnosis
Genitourinary
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Cancer Diagnosis
Head and Neck
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Cancer Diagnosis
Skin
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Cancer Diagnosis
Other
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Cancer Stage at Diagnosis
I
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Cancer Stage at Diagnosis
II
|
12 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Cancer Stage at Diagnosis
III
|
30 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Cancer Stage at Diagnosis
IV
|
59 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Marital Status
Married
|
35 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Marital Status
Unmarried
|
70 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
138 Participants
n=27 Participants
|
|
Total Baseline Health Care Costs
|
14052 US Dollars
n=93 Participants
|
11455 US Dollars
n=4 Participants
|
13090 US Dollars
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 months after each patient enrollmentFeasibility 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
| 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 enrollmentEmergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
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 enrollmentEmergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
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 enrollmentHospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
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 enrollmentHospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
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 enrollmentHospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
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 enrollmentPalliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
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 enrollmentPalliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
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
| 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 monthsEach 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
| 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