Enhancing Community Capacity to Improve Cancer Care Delivery

Not Applicable

Completed

• Conditions: End of Life; Cancer
• Interventions: Behavioral: Program participants; Other: Usual Care

• Registration Number: NCT04107116
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 832

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group Arm	Program 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.
Intervention Group Arm	Usual Care	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.
Control Group Arm	Usual Care	The control group arm will receive usual care as provided by their local oncologists.

Primary Outcome Measures

Name	Time	Method
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen	12 months after patient enrollment	Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale) at 12 months. The scale is a 10-point scale measured from 0 to 10 where 0 represents no symptom and 10 represents the worse severity of the symptom. The scale measures 10 symptoms.
Personal Health Questionnaire-9 (PHQ-9) Depression Screen	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.

Secondary Outcome Measures

Name	Time	Method
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)	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 % of patients with emergency department visits between study arms.
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)	12 months after patient enrollment	Hospitalization 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 hospitalizations between the two study arms.
% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)	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.
% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)	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.
Total Health Care Costs (Claims Review)	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.
% of patients with an Acute Care Facility Death (Chart Review)	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.
% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)	30 days prior to death for patients who died at 12-months follow-up	Emergency Department 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.
% of patients with a Hospice Consult in the last 30 days of life (Chart Review)	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.
Total Costs of Care (Claims Review)	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.

Trial Locations

Locations (1)

Oncology Institute for Hope and Innovation; 🇺🇸 Los Angeles, California, United States