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Tier - Palliative Care for Lung Cancer (TIER-PC Trial)

N/A
Recruiting
Led By Laura P Gelfman, MD, MPH
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
> 18 years of age
Capacity to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

TIER-PC Trial Summary

This trial, called TIER-PC, is a way of delivering palliative care that adjusts based on a patient's needs. It is based on a program called PC@H, which provides pall

Who is the study for?
This trial is for adults with advanced heart failure or cancer (intestinal, gastrointestinal, stomach, lung) who need different levels of palliative care. The care level adjusts as symptoms and personal care abilities change. Patients must be able to receive home-based care.Check my eligibility
What is being tested?
The TIER-PC model is being tested to provide adaptive palliative care at home. It adds more healthcare professionals to the patient's team as their condition worsens, ranging from a community health worker to a physician in the most severe cases.See study design
What are the potential side effects?
Since this trial focuses on non-medical interventions like palliative care services rather than drugs or medical procedures, it does not have typical side effects. However, changes in emotional well-being due to varying levels of support may occur.

TIER-PC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I understand and can agree to the study's procedures and risks.
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I have had multiple hospital visits due to heart failure or cancer.
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I can care for myself and perform daily activities.

TIER-PC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of screened eligible patients
Secondary outcome measures
Edmonton Symptom Assessment Scale (ESAS)
Number of TIER-PC intervention visits received per patient per month
Number of participant emergency department (ED) visits
+5 more

TIER-PC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tier - Palliative CareExperimental Treatment1 Intervention
Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
Group II: Usual careActive Control1 Intervention
Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,566 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,501 Total Patients Enrolled
Laura P Gelfman, MD, MPHPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

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

Is the enrollment phase for this investigation currently ongoing?

"Indeed, the details on clinicaltrials.gov indicate that this study is actively seeking individuals to participate. The trial was initially posted on January 1st, 2024 and most recently updated on January 19th, 2024. The research team aims to recruit a total of 60 patients from one designated site."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Indeed, the information provided on clinicaltrials.gov indicates that this trial is presently in the recruitment phase. The study was first posted on January 1st, 2024 and was last updated on January 19th, 2024. The researchers aim to enroll a total of 60 participants from a single designated site."

Answered by AI
~40 spots leftby Jul 2025