Clinical trial NCT04107116: Enhancing Community Capacity to Improve Cancer Care Delivery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life
Cancer
Keywords: cancer end of life patient-centered
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 832
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
timeFrame: Baseline (at time of patient enrollment)
measure: Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
timeFrame: 6 months after patient enrollment
measure: Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
timeFrame: 12 months after patient enrollment
measure: Personal Health Questionnaire-9 (PHQ-9) Depression Screen
timeFrame: Baseline (at time of patient enrollment)
measure: Personal Health Questionnaire-9 (PHQ-9) Depression Screen
timeFrame: 6 months after patient enrollment
measure: Personal Health Questionnaire-9 (PHQ-9) Depression Screen
timeFrame: 12 months after patient enrollment
Secondary outcomes:
measure: Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Total Health Care Costs (Claims Review)
timeFrame: 12 months after patient enrollment
measure: Number of Patients With an Acute Care Facility Death (Chart Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
measure: Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
measure: Number of Hospitalization Visits in the Last 30 Days of Life (Chart Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
measure: Number of Patients With a Hospice Consult in the Last 30 Days of Life (Chart Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
measure: Total Costs of Care (Claims Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Oncology Institute for Hope and Innovation
state: California
Study officials:
affiliation: Stanford University
name: Manali I Patel, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References: