Enhancing Community Capacity to Improve Cancer Care Delivery

NCT ID: NCT04107116

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 832 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2021-09-30

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.

Conditions

End of Life; Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Program participants

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Usual care as provided by local oncologists

Control Group Arm

The control group arm will receive usual care as provided by their local oncologists.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual care as provided by local oncologists

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

Usual care as provided by local oncologists

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Manali Indravadan Patel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manali I Patel, MD MPH MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Oncology Institute for Hope and Innovation

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

455

Identifier Type: -

Identifier Source: org_study_id