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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04107116
Other study ID # 455
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2015
Est. completion date September 30, 2021

Study information

Verified date July 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 832
Est. completion date September 30, 2021
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Other:
Usual Care
Usual care as provided by local oncologists

Locations

Country Name City State
United States Oncology Institute for Hope and Innovation Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (at time of patient enrollment)
Primary 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. 6 months after patient enrollment
Primary 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. 12 months after patient enrollment
Primary 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. Baseline (at time of patient enrollment)
Primary 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. 6 months after patient enrollment
Primary 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. 12 months after patient enrollment
Secondary % 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
Secondary % 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 % 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. 12 months after patient enrollment
Secondary 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. 12 months after patient enrollment
Secondary % 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. 30 days prior to death for patients who died at 12-months follow-up
Secondary % 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. 30 days prior to death for patients who died at 12-months follow-up
Secondary % 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. 30 days prior to death for patients who died at 12-months follow-up
Secondary % 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. 30 days prior to death for patients who died at 12-months follow-up
Secondary 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. 30 days prior to death for patients who died at 12-months follow-up
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