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Completed

NCT Number: NCT04463992

Lay Health Worker Expanded Intervention in Community Oncology Practices

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.

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Key information

Conditions

End of Life Cancer Death Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Oncology Institute of Hope and Innovation, Tucson, Arizona, United States

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About this study

All patients with newly diagnosed cancer, over the age of 75 will be randomized into the CareMore Pilot 2 Program with 200 randomized to the intervention grou and 200 randomized to the control group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed or relapsed cancer diagnosis.
  • 75 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

Exclusion criteria

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

Treatment and study plan

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.

Usual Care

Other

Usual care as provided by local oncologists

Primary outcomes

  1. % of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Total Health Care Costs (Claims Review)

    Time frame: 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.

  3. % of patients with an Acute Care Facility Death (Chart Review)

    Time frame: 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.

  4. % of patients with Emergency Department Visit in the last 30 days of life (Chart Review)

    Time frame: 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.

  5. % of patients with Hospitalization Visits in the last 30 days of life (Chart Review)

    Time frame: 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.

  6. % of patients with a Hospice Consult in the last 30 days of life (Chart Review)

    Time frame: 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.

  7. Total Costs of Care (Claims Review)

    Time frame: Time of enrollment to 12 months followup or death, whichever is first

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2020
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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