NCT04463992

Lay Health Worker Expanded Intervention in Community Oncology Practices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 75 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• End of Life
• Cancer

Interventions

Type	Name	Description
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 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

Timeline

• Start date: 2020-10-05
• Primary completion: 2024-10-17
• Completion: 2024-10-17
• First posted: 2020-07-09
• Last updated: 2025-04-27

Locations

2 sites across 1 country: United States