Trial Outcomes & Findings for Enhancing Community Capacity to Improve Cancer Care Delivery (NCT NCT04107116)

Last Updated: 2025-02-27

Results Overview

Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). 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).

Recruitment status

COMPLETED

Study phase

Target enrollment

832 participants

Primary outcome timeframe

Baseline (at time of patient enrollment)

Results posted on

2025-02-27

Participant Flow

The study was conducted with participants care for in 9 of 10 oncology clinics within the Oncology Institute of Hope and Innovation. Participants were screened by a new patient coordinator, then enrolled from 11/1/2016 to 10/31/2017 and were followed up with for 12 months after or death.

One oncology clinic was excluded due to involvement in a previously reported intervention in the sources. The study also excluded clinic patients that did not receive medical oncology care.

Participant milestones

Participant milestones
Measure	Intervention Group Arm Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Overall Study STARTED	425	407
Overall Study COMPLETED	425	407
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The total participant population was broken down into each of the 9 individual clinic sites, and then analyzed.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline (at time of patient enrollment)

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen	7 total score on a scale Interval 0.0 to 10.0	7 total score on a scale Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: 6 months after patient enrollment

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=367 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=336 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen	8.2 score on a scale Interval 0.0 to 9.0	9.8 score on a scale Interval 5.0 to 10.0

PRIMARY outcome

Timeframe: 12 months after patient enrollment

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=245 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=218 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen	7 score on a scale Interval 0.0 to 7.0	9.8 score on a scale Interval 6.0 to 10.0

PRIMARY outcome

Timeframe: Baseline (at time of patient enrollment)

Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at baseline. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Personal Health Questionnaire-9 (PHQ-9) Depression Screen	2.9 units on a scale Interval 0.0 to 27.0	2.7 units on a scale Interval 0.0 to 27.0

PRIMARY outcome

Timeframe: 6 months after patient enrollment

Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 6 months. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=367 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=336 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Personal Health Questionnaire-9 (PHQ-9) Depression Screen	2.5 score on a scale Interval 0.0 to 27.0	2.9 score on a scale Interval 0.0 to 27.0

PRIMARY outcome

Timeframe: 12 months after patient enrollment

Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 12 months. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=245 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=218 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Personal Health Questionnaire-9 (PHQ-9) Depression Screen	1.9 score on a scale Interval 0.0 to 27.0	3.9 score on a scale Interval 0.0 to 27.0

SECONDARY outcome

Timeframe: 12 months after patient enrollment

Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the number of visits (per 1000 members/year) with emergency department visits between study arms.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review)	0.43 visits per 1000 members/yr.	0.57 visits per 1000 members/yr.

SECONDARY outcome

Timeframe: 12 months after patient enrollment

Hospital use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the number of visits (per 1000 members/year) with hospital use between study arms.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review)	0.54 visits per 1000 members/yr.	0.72 visits per 1000 members/yr.

SECONDARY outcome

Timeframe: 12 months after patient enrollment

Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review)	207 Participants	101 Participants

SECONDARY outcome

Timeframe: 12 months after patient enrollment

Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Total Health Care Costs (Claims Review)	17,869 $USD	18,473 $USD

SECONDARY outcome

Timeframe: 30 days prior to death for patients who died at 12-months follow-up

Acute Care Facility Deaths for each patient will be abstracted by electronic medical record chart review and claims review for each patient who has died at 12-months followup. We will evaluate comparisons of Acute Care Facility Deaths between study arms.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Number of Patients With an Acute Care Facility Death (Chart Review)	18 Participants	30 Participants

SECONDARY outcome

Timeframe: 30 days prior to death for patients who died at 12-months follow-up

Emergency Department (acute care) use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review)	0.10 acute care visits Standard Deviation 0.30	0.30 acute care visits Standard Deviation 0.46

SECONDARY outcome

Timeframe: 30 days prior to death for patients who died at 12-months follow-up

Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Number of Hospitalization Visits in the Last 30 Days of Life (Chart Review)	0.27 hospitalizations Standard Deviation 0.44	0.43 hospitalizations Standard Deviation 0.82

SECONDARY outcome

Timeframe: 30 days prior to death for patients who died at 12-months follow-up

Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Number of Patients With a Hospice Consult in the Last 30 Days of Life (Chart Review)	125 Participants	79 Participants

SECONDARY outcome

Timeframe: 30 days prior to death for patients who died at 12-months follow-up

Total costs of care for each patient will be obtained through claims data for each patient for each patient who has died. We will evaluate comparisons of Total costs of care between study arms.

Outcome measures

Outcome measures
Measure	Intervention Group Arm n=425 Participants Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. Usual Care: Usual care as provided by local oncologists	Control Group Arm n=407 Participants The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists
Total Costs of Care (Claims Review)	3,602 $USD	12,726 $USD

Adverse Events

Intervention Group Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 180 deaths

Control Group Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 189 deaths

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

Phone: 650-723-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place