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Tier Palliative Care for Advanced Heart Failure or Cancer

This study is testing a new way to provide palliative care, called Tier-Palliative Care (TIER-PC), for people with advanced heart failure or certain advanced cancers (lung, non-colorectal gastrointestinal, or triple negative breast cancer). TIER-PC aims to give you the right level of support at the right time, increasing care as your symptoms worsen. Some participants will also receive a Community Health Worker who acts as a health coach. The study wants to see if TIER-PC improves your symptoms and quality of life, and helps you discuss your goals for care. To join, you must be at least 18 years old and have advanced heart failure or one of the specified advanced cancers, along with certain hospitalization history and a good ability to perform daily activities. The study is currently unclear about its recruitment status and plans to enroll 400 people.

Study design
This is an interventional study that plans to enroll 400 participants. It is a randomized controlled trial, meaning participants will be assigned by chance to either receive TIER-PC or usual care with a community health worker.
What's involved
Participants will have ongoing monitoring and input from a clinical team, which may include video, telephone, and in-person visits. You will also have access to a 24-hour telephone advice line.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms, quality of life, and goals of care discussions will be measured at 12 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07391956

Tier Palliative Care For Patients With Advanced Heart Failure or Cancer

Not Yet Recruiting
NAAges 18+InterventionalHealth services
Icahn School of Medicine at Mount Sinai
~400 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Tier-Palliative CareCommunity Health Worker

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Edmonton Symptom Assessment Scale (ESAS)
Measured over 12 months
+2 more outcomes measured

Conditions

Advanced Heart Failure
Advanced Non-Colorectal Gastrointestinal Cancer
Advanced Lung Cancer
Advanced Triple Negative Breast Cancer

Explore related trials

Breast CarcinomaHeart FailureLung CarcinomaMalignant Digestive System Neoplasm

Where it's being run

5 sites across 1 states
New York5

Study leadership

  • Laura Gelfman · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Christian Espino
[email protected]
212-421-4632
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12 months or
Advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric, hepatobiliary, small bowel, esophageal) or tripe negative breast cancer with one hospitalization within the last 6 months
KPS \> or = 50% (ECOG 0, 1 or 2)
\> 2 outpatient MSHS visits in prior 12 months
Manhattan or Queens residence
Capacity to provide informed consent
English or Spanish fluency
\> or = 18 years of age

Exclusion

Diagnoses of both cancer and advanced HF
Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosis and does not follow typical trajectory
Patients with \> 1 visit to Outpatient Supportive Oncology/Cardiology visit
Patients with last visit to Outpatient Supportive Oncology/Cardiology \< 3 months ago
Previous receipt of a ventricular assist device or previous heart transplantation
Receiving hospice care prior to study enrollment or enrolled in another study of a palliative care patient/caregiver intervention
Living in a facility (subacute rehab, long-term care facility, hospice facility or residence)
Callahan 6-Item Cognitive Screening score ≤3

What this trial measures

  • Edmonton Symptom Assessment Scale (ESAS)12 months

    Patient symptoms: Edmonton Symptom Assessment Scale (ESAS), 9 items, each item is scored on a 10-point scale, total score ranges from 0-90, higher scores indicate more symptoms.

  • Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)12 months

    Patient quality of life: Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal), a 46-item QoL questionnaire validated in patients with advanced disease. Each item is scored on a 5-point likert scale. Total score ranges from 0-184, higher scores indicate better quality of life

  • Patient-reported goals of care discussion12 months

    Patient-reported Goals of Care Discussions: "Have you ever discussed with this doctor the kind of medical care you would want if you were too sick to speak for yourself?" Response: Yes/No