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Completed

NCT Number: NCT04107116

Enhancing Community Capacity to Improve Cancer Care Delivery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncology Institute for Hope and Innovation

Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

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 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. Edmonton Symptom Assessment Scale (ESAS) Symptom Screen

    Time frame: Baseline (at time of patient enrollment)

    Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).

  2. Edmonton Symptom Assessment Scale (ESAS) Symptom Screen

    Time frame: 6 months after patient enrollment

    Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).

  3. Edmonton Symptom Assessment Scale (ESAS) Symptom Screen

    Time frame: 12 months after patient enrollment

    Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).

  4. Personal Health Questionnaire-9 (PHQ-9) Depression Screen

    Time frame: Baseline (at time of patient enrollment)

    Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at baseline. 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.

  5. Personal Health Questionnaire-9 (PHQ-9) Depression Screen

    Time frame: 6 months after patient enrollment

    Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 6 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.

  6. Personal Health Questionnaire-9 (PHQ-9) Depression Screen

    Time frame: 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 outcomes

  1. Incidence of Emergency Department Visits 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 number of visits (per 1000 members/year) with emergency department visits between study arms.

  2. Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review)

    Time frame: 12 months after patient enrollment

    Hospital 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 number of visits (per 1000 members/year) with hospital use between study arms.

  3. Number 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.

  4. 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.

  5. Number 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.

  6. Number of 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 (acute care) 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.

  7. Number of 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.

  8. Number 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.

  9. Total Costs of Care (Claims Review)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Sep 27, 2019
Registry last updated
Feb 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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