Enhancing Community Capacity to Improve Cancer Care Delivery

Enhancing Community Capacity to Improve Cancer Care Delivery: The Effect of a Lay Health Worker Intervention on Patient-reported Symptoms, Healthcare Use, Total Costs of Care, and End-of-life Care Delivery

Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a a lay health worker (LHW)-led symptom screening intervention was developed for patients with advanced cancer. This intervention will be expanded to all patients with cancer and the LHW will be trained to refer patients to palliative care and behavioral health. This intervention will evaluate the effect on symptom-burden, survival, healthcare use, and total costs.

Study Overview

• Status: Completed
• Conditions: Cancer; End of Life
• Intervention / Treatment: Other: Usual Care; Behavioral: Program participants

Detailed Description

From 11/1/2016 - 9/30/2018, all newly diagnosed Medicare Advantage enrollees with solid or hematologic malignancies were enrolled in the intervention. Outcomes were compared outcomes to patients in the year prior (control arm). The primary outcome was change in symptoms using the Edmonton Symptom Assessment Scale (ESAS) and Personal Health Questionnaire-9 (PHQ-9) at baseline, 6- and 12-months post-enrollment. Secondary outcomes were between-group comparison of survival, 12-month healthcare use and costs.

• Study Type: Interventional
• Enrollment (Actual): 832
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States
      • Oncology Institute for Hope and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Newly diagnosed with cancer
• Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
• Must be 18 years or older.
• Must have capacity to verbally consent

Exclusion Criteria:

-Inability to consent to the study due to lack of capacity as documented by the referring physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Usual Care; Usual care as provided by local oncologists; Behavioral: 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.
Active Comparator: Control Group Arm; The control group arm will receive usual care as provided by their local oncologists.	Other: Usual Care; Usual care as provided by local oncologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Health Questionnaire-9 (PHQ-9) Depression Screen	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.	Baseline (at time of patient enrollment)
Personal Health Questionnaire-9 (PHQ-9) Depression Screen	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.	6 months after patient enrollment
Personal Health Questionnaire-9 (PHQ-9) Depression Screen	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.	12 months after patient enrollment
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen	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).	Baseline (at time of patient enrollment)
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen	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).	6 months after patient enrollment
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen	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).	12 months after patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Health Care Costs (Claims Review)	Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.	12 months after patient enrollment
Total Costs of Care (Claims Review)	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.	30 days prior to death for patients who died at 12-months follow-up
Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review)	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.	12 months after patient enrollment
Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review)	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.	12 months after patient enrollment
Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review)	Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Number of Patients With an Acute Care Facility Death (Chart Review)	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.	30 days prior to death for patients who died at 12-months follow-up
Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review)	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.	30 days prior to death for patients who died at 12-months follow-up
Number of Hospitalization Visits in the Last 30 Days of Life (Chart Review)	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.	30 days prior to death for patients who died at 12-months follow-up
Number of Patients With a Hospice Consult in the Last 30 Days of Life (Chart Review)	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.	30 days prior to death for patients who died at 12-months follow-up

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Manali I Patel, MD MPH MS, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cancer end of life patient-centered
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: 455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No