Trial Outcomes & Findings for Lay Health Worker Led Symptom Assessment Intervention (NCT NCT03737058)
NCT ID: NCT03737058
Last Updated: 2025-02-27
Results Overview
ESAS measures participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).
COMPLETED
288 participants
12 months after patient enrollment
2025-02-27
Participant Flow
The study was implemented with CareMore Health and the Oncology Institute of Hope and Innovation, which has 26 locations across southern California. Enrollment was conducted between November 1, 2015 and September 30, 2016. Each patient participated for 12 months or until death, whichever occurred first.
Patients were excluded from the intervention and control groups if they did not require medical oncology services.
Participant milestones
| Measure |
Control Group
All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.
|
Intervention Group
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
186
|
|
Overall Study
COMPLETED
|
100
|
183
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lay Health Worker Led Symptom Assessment Intervention
Baseline characteristics by cohort
| Measure |
Control Group
n=102 Participants
All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.
|
Intervention Group
n=186 Participants
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
102 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Age, Continuous
|
79 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
79 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
79 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, No. (%) · Non-Hispanic White
|
49 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, No. (%) · Hispanic
|
42 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, No. (%) · Non-Hispanic Black
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, No. (%) · Asian Pacific Islander
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, No. (%) · Native Hawaiian/Alaskan Native/American Indian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cancer Diagnosis
Thoracic
|
13 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Cancer Diagnosis
GI
|
29 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Cancer Diagnosis
Genitourinary
|
15 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Cancer Diagnosis
Malignant hematologic conditions
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Cancer Diagnosis
Breast
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Cancer Diagnosis
Other (i.e. skin, brain, bone, soft tissues, head/neck)
|
13 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Cancer Stage
3
|
47 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Cancer Stage
4
|
55 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after patient enrollmentPopulation: Only participants in the intervention group were invited to complete the ESAS.
ESAS measures participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).
Outcome measures
| Measure |
Control Group
All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.
|
Intervention Group
n=186 Participants
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.
|
|---|---|---|
|
Edmonton Symptom Assessment Scale Score (ESAS)
Symptom score at enrollment
|
—
|
9.6 score on a scale
Interval 0.0 to 10.0
|
|
Edmonton Symptom Assessment Scale Score (ESAS)
Symptom score after 12 months
|
—
|
7.2 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: 12 months after patient enrollmentEmergency Department use for each patient abstracted from medical claims data review for each patient at 12 months after enrollment.
Outcome measures
| Measure |
Control Group
n=102 Participants
All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.
|
Intervention Group
n=186 Participants
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.
|
|---|---|---|
|
Incidence of Emergency Department Visits
|
0.92 visits per 1000 members/yr.
|
0.61 visits per 1000 members/yr.
|
SECONDARY outcome
Timeframe: 12 months after patient enrollmentHospitalization Use for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
Outcome measures
| Measure |
Control Group
n=102 Participants
All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.
|
Intervention Group
n=186 Participants
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.
|
|---|---|---|
|
Hospitalization Visits (Claims Review)
No. of Admissions
|
1.02 number of visits
Standard Deviation 1.44
|
0.72 number of visits
Standard Deviation 0.96
|
|
Hospitalization Visits (Claims Review)
No. of readmissions
|
0.10 number of visits
Standard Deviation 0.41
|
0.18 number of visits
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: 12 months after patient enrollmentIntensive Care Unit Visits for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
Outcome measures
| Measure |
Control Group
n=102 Participants
All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.
|
Intervention Group
n=186 Participants
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.
|
|---|---|---|
|
Intensive Care Unit Visits (Claims Review)
|
0.66 number of visits
Standard Deviation 1.23
|
0.60 number of visits
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: 12 months after patient enrollmentTotal Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
Outcome measures
| Measure |
Control Group
n=102 Participants
All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.
|
Intervention Group
n=186 Participants
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.
|
|---|---|---|
|
Total Health Care Costs (Claims Review)
|
31,946 $USD
|
21,266 $USD
|
SECONDARY outcome
Timeframe: Change in Patient Satisfaction with Care from baseline to 5 months.Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 5 months. We will measure the change in satisfaction from calculated as the value at 5 months minus the baseline value. 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 12 months.
Outcome measures
| Measure |
Control Group
n=100 Participants
All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.
|
Intervention Group
n=183 Participants
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.
|
|---|---|---|
|
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
Baseline (diagnosis)
|
8.34 score on a scale
Standard Deviation 1.83
|
8.10 score on a scale
Standard Deviation 1.80
|
|
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
5-month follow-up
|
8.10 score on a scale
Standard Deviation 1.96
|
9.25 score on a scale
Standard Deviation 1.03
|
|
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
Change at 5-months
|
-0.23 score on a scale
Standard Deviation 1.88
|
1.15 score on a scale
Standard Deviation 1.79
|
Adverse Events
Control Group
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Manali I Patel, MD MPH MS
Stanford University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place