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Lay Health Worker Intervention for Cancer (LEAPS Trial)

N/A

Waitlist Available

Led By Manali I Patel, MD MPH MS

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up last 30 days of life up to 12 months from patient enrollment

Awards & highlights

LEAPS Trial Summary

This trial aims to see if having a lay health worker helps patients with cancer feel more satisfied with their care, and if it improves quality of life and health resource utilization.

Eligible Conditions

End of Life
Cancer

LEAPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ last 30 days of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~last 30 days of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and last 30 days of life for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Advance Directive Documentation (Chart Review)

Emergency Department Visit (Chart Review)

Goals of Care Documentation (Chart Review)

+12 more

LEAPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Group ArmExperimental Treatment2 Interventions

Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists.

Group II: Control Group ArmActive Control1 Intervention

The control group arm will receive usual care as provided by Unite Here Health and their local oncologists.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lay Health Worker Intervention

2013

N/A

~400

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,386 Previous Clinical Trials

17,333,848 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,428 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

380 Previous Clinical Trials

1,215,494 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it currently possible to sign up for this research trial?

"Data from clinicaltrials.gov suggests that this trial has finished recruiting participants, as the last edit to its information was made on October 31st 2022. Nevertheless, there are 570 other ongoing studies currently looking for patients."

Answered by AI

What is the ultimate objective of this research endeavor?

"The primary outcome of this clinical trial, to be assessed within four months from patient enrollment, is the alteration in their Quality of Life as measured by the Functional Assessment of Cancer Therapy - General Survey. Secondary objectives include Hospice Use (abstracted via chart review for patients who have deceased within 12 months), Hospitalization Visits (also abstracted through chart review) and Patient Activation using a validated survey at 12 month intervals after study enrollment."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

A Randomized Trial of a Multi-level Intervention to Improve Advance Care Planning and Symptom Management Among Low-income and Minority Employees Diagnosed with Cancer in Outpatient Community Settings

Patel, Manali I., Sana Khateeb, and Tumaini Coker. 2020. “A Randomized Trial of a Multi-level Intervention to Improve Advance Care Planning and Symptom Management Among Low-income and Minority Employees Diagnosed with Cancer in Outpatient Community Settings”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2020.105971.

clinicaltrials.govStudy

Lay Health Worker Engage, Educate, and Encourage Patients to Share

Manali Indravadan Patel 2018. "Lay Health Worker Engage, Educate, and Encourage Patients to Share". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03699748.