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Enhancing Community Capacity to Improve Cancer Care Delivery

Primary Purpose

End of Life, Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Program participants
Usual Care
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End of Life focused on measuring cancer end of life patient-centered

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology Institute for Hope and Innovation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group Arm

Control Group Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). 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.
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale) at 6 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.
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
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
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.
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
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.
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
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

% 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.
% 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.
% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)
Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Total Health Care Costs (Claims Review)
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)
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)
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 Hospitalization Visits in the last 30 days of life (Chart Review)
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.
% of patients with a Hospice Consult in the last 30 days of life (Chart Review)
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)
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.

Full Information

First Posted
September 24, 2019
Last Updated
July 18, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04107116
Brief Title
Enhancing Community Capacity to Improve Cancer Care Delivery
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life, Cancer
Keywords
cancer end of life patient-centered

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
832 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group Arm
Arm Type
Active Comparator
Arm Description
The control group arm will receive usual care as provided by their local oncologists.
Intervention Type
Behavioral
Intervention Name(s)
Program participants
Intervention Description
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
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care as provided by local oncologists
Primary Outcome Measure Information:
Title
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
Description
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). 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.
Time Frame
Baseline (at time of patient enrollment)
Title
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
Description
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale) at 6 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.
Time Frame
6 months after patient enrollment
Title
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
Description
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.
Time Frame
12 months after patient enrollment
Title
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
Description
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.
Time Frame
Baseline (at time of patient enrollment)
Title
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
Description
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.
Time Frame
6 months after patient enrollment
Title
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
Description
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.
Time Frame
12 months after patient enrollment
Secondary Outcome Measure Information:
Title
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
Description
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.
Time Frame
12 months after patient enrollment
Title
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
Description
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.
Time Frame
12 months after patient enrollment
Title
% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)
Description
Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time Frame
12 months after patient enrollment
Title
Total Health Care Costs (Claims Review)
Description
Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
Time Frame
12 months after patient enrollment
Title
% of patients with an Acute Care Facility Death (Chart Review)
Description
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
Title
% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)
Description
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
Title
% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)
Description
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
Title
% of patients with a Hospice Consult in the last 30 days of life (Chart Review)
Description
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
Title
Total Costs of Care (Claims Review)
Description
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manali I Patel, MD MPH MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Institute for Hope and Innovation
City
Los Angeles
State/Province
California
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing Community Capacity to Improve Cancer Care Delivery

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