Lay Health Worker Expanded Intervention in Community Oncology Practices

NCT04463992 | Completed

• 1 other identifier: 57643
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 2

Brief Summary

Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. In pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. This intervention will be expanded across several clinics to evaluate the impact of the LHW intervention on with cancer and the LHW will be trained to refer patients to palliative care. This randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.

Conditions

End of Life; Cancer

Keywords

cancer end of life patient-centered

Outcome Measures

Primary Outcomes (2)

• % of patients with Emergency Department Visit 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 % of patients with emergency department visits between study arms.

  12 months after patient enrollment

• % of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)

  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.

  12 months after patient enrollment

Secondary Outcomes (7)

• % of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)

  12 months after patient enrollment

• Total Health Care Costs (Claims Review)

  12 months after patient 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

• % 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

• % 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

Study Arms (2)

Intervention Group Arm

EXPERIMENTAL

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.

Behavioral: Program participants; Other: Usual Care

Behavioral:Program participants

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Program participants 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 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 Group Arm

Usual Care OTHER

Usual care as provided by local oncologists

Behavioral:Program participants; Intervention Group Arm

Eligibility Criteria

• Age: 75 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

The Oncology Institute of Hope and Innovation

Tucson, Arizona, 85710, United States

Location

The Oncology Institute of Hope and Innovation

Henderson, Nevada, 89052, United States

Location

Related Publications (1)

• Patel MI, Voskanyan M, Agajanian H, Agajanian R, Podnos Y, Milstein A. A Lay Health Worker-Led Symptom Intervention and Acute Care Use in Older Adults With Cancer: A Randomized Clinical Trial. JAMA. 2025 Dec 30:e2523403. doi: 10.1001/jama.2025.23403. Online ahead of print.

  PMID: 41468027 DERIVED

MeSH Terms

Conditions

Death; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manali I Patel, MD MPH MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: July 9, 2020
• Study Start: October 5, 2020
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)