Clinical Trials Directory

Trials / Completed

CompletedNCT04107116

Enhancing Community Capacity to Improve Cancer Care Delivery

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
832 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALProgram participantsThe 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.
OTHERUsual CareUsual care as provided by local oncologists

Timeline

Start date
2016-11-01
Primary completion
2020-09-30
Completion
2021-09-30
First posted
2019-09-27
Last updated
2025-02-27
Results posted
2025-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04107116. Inclusion in this directory is not an endorsement.