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Lay Health Worker Intervention for Cancer

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
Must have capacity to verbally consent
75 years or older with an odd medical record #
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days prior to death for patients who died at 12-months follow-up
Awards & highlights

Study Summary

This trial will test whether a lay health worker-led symptom screening intervention can improve symptoms and reduce healthcare use for patients with cancer.

Who is the study for?
This trial is for individuals aged 75 or older with an odd medical record number, who can verbally consent and have a new or relapsed cancer diagnosis. It's not open to those unable to consent due to lack of capacity as noted by their doctor.Check my eligibility
What is being tested?
The study tests a program where lay health workers help manage symptoms in cancer patients. The goal is to see if this reduces healthcare use and costs at the end of life, and how it affects referrals to palliative care and hospice services.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention focusing on symptom management rather than medication or procedures, there are no direct side effects associated with typical drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and verbally agree to participate.
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I am 75 or older with an odd-numbered medical record.
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My cancer is either newly diagnosed or has come back.
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My cancer has returned or worsened, confirmed by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days prior to death for patients who died at 12-months follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days prior to death for patients who died at 12-months follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
Secondary outcome measures
% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)
% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)
% of patients with a Hospice Consult in the last 30 days of life (Chart Review)
+4 more

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: proactive symptom assessments for patients for up to 12-months.
Group II: Behavioral:Program participantsActive Control1 Intervention
The control group arm will receive usual care as provided by their local oncologists.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Program participants
2015
N/A
~840

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,527 Total Patients Enrolled
Manali I Patel, MD MPH MSPrincipal InvestigatorStanford University
3 Previous Clinical Trials
1,032 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 there an opportunity to partake in this research study?

"This medical trial requires 400 participants who are 75 years or older, with a pre-existing odd numbered medical record. Additionally, the individuals must have recently been diagnosed or relapsed from cancer and be of sound mind to give verbal consent for participation."

Answered by AI

What purpose does this inquiry have?

"For the purpose of this trial, primary outcomes will be observed over a 12-month window after patient enrollment. This includes an evaluation of the percentage of patients who visited Emergency Departments and Hospitalization Visits in their last 30 days alive, as well as Acute Care Facility Deaths noted from electronic medical record chart reviews and claims information. Cost comparisons between study arms are also to be calculated through Claims Reviews post-12 months followup."

Answered by AI

Are there any unused patient slots available in this experiment?

"According to information on clinicaltrials.gov, this particular investigation is not actively searching for participants at the moment. The trial was initiated on October 5th 2020 and updated lastly on July 8th 2022. While there are no recruitment opportunities with this study right now, 569 other trials are presently looking for enrolment across various sites."

Answered by AI

Is the participant pool of this research study limited to adults above twenty years old?

"The eligibility for this clinical trial is restricted to the elderly, with a minimum age of 75 and maximum age of 100. Contrarily, there are 85 trials open to individuals younger than 18 and 500 medical studies available for those over 65 years old."

Answered by AI
~36 spots leftby Aug 2024