Palliative Care for Heart Failure or Cancer

(TIER-PC Trial)

Overseen By Laura P Gelfman, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Cancer and heart failure, Lung cancer mutation, Supportive oncology/cardiology visits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of providing palliative care at home for individuals with advanced heart failure or certain cancers, such as pancreatic or stomach cancer. The goal is to adjust care levels as symptoms change, starting with support from a community health worker and potentially adding specialists like nurses or doctors as needed. It is ideal for Manhattan residents recently hospitalized for heart failure or specific cancers who can still perform some daily activities. Participants will either receive standard care or join a special team-based care approach, known as Tier - Palliative Care (TIER-PC or Palliative Care at Home, PC@H). The trial aims to improve comfort and care quality as health conditions progress. As an unphased trial, this study provides a unique opportunity to enhance the care experience and contribute to innovative healthcare solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this palliative care model is safe for patients with heart failure or cancer?

Research has shown that palliative care, which focuses on comfort and quality of life, can improve treatment outcomes for patients with heart failure and advanced cancer. Patients generally find this type of care easy to handle. Studies suggest it enhances quality of life without causing additional stress or side effects. Patients often report better symptom management and an overall sense of well-being.

Palliative care does not involve new drugs or risky procedures, so it usually results in fewer adverse side effects. The care team typically includes healthcare providers such as social workers, nurses, and doctors, who help manage symptoms and offer support.

This approach is already widely used and considered safe for patients with serious illnesses. For those considering joining a trial for palliative care, this safety record might be reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the innovative palliative care approach for heart failure and cancer because it brings a comprehensive, team-based approach to patient care. Unlike standard options, where patients are managed primarily by their main physician, this treatment involves an interdisciplinary team, including a social worker, nurse, community health worker, nurse practitioner, and physician. This coordinated effort aims to address not only the medical needs but also the emotional and social aspects of living with serious illnesses, potentially improving overall patient well-being and quality of life. By integrating diverse expertise, this approach could offer more personalized and holistic support compared to traditional care.

What evidence suggests that this trial's palliative care model could be effective for heart failure or cancer?

Research has shown that palliative care can improve outcomes for patients with heart failure and advanced cancer by enhancing quality of life and better managing symptoms. In this trial, some participants will receive Tier - Palliative Care, involving a team of healthcare professionals, including social workers, nurses, and doctors, who collaborate to meet each patient's needs. Studies indicate that patients receiving palliative care have fewer hospital visits and report higher satisfaction with their care. Evidence suggests these interventions lead to better symptom control and emotional support, significantly impacting patients' lives. ^{1 2 5 6 7}

Who Is on the Research Team?

Laura P Gelfman, MD, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am older than 18 years.

I understand and can agree to the study's procedures and risks.

I have had multiple hospital visits due to heart failure or cancer.

Exclusion Criteria

Callahan 6-Item Cognitive Screening score ≤3

I have been diagnosed with both cancer and advanced heart failure.

I visited a cancer or heart support doctor less than 3 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 months

Active Enrollment

Participants are enrolled and receive either usual care or the TIER-PC intervention

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after the active enrollment period

3 months

Data Analysis

Data analysis is conducted to evaluate the efficacy of the TIER-PC intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Tier - Palliative Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Tier - Palliative Care Experimental Treatment 1 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 care Active Control 1 Intervention

Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

In a study of 705 patients with stage IV cancer, 47% were referred to palliative care (PC), with nearly half of those referrals occurring early (within 60 days of diagnosis), highlighting the importance of timely access to supportive care.

Patients referred to PC were more likely to receive hospice care (79%) compared to those not referred (55%), indicating that early palliative care can enhance end-of-life support and improve overall patient and family experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How, when, and why individuals with stage IV cancer seen in an outpatient setting are referred to palliative care: a mixed methods study. Dillon, EC., Meehan, A., Li, J., et al.[2021]

In a study involving 150 patients with advanced heart failure, all participants were on multiple medications (polypharmacy) at the start, and this number increased over time for both standard care and palliative care groups.

The palliative care intervention did not significantly reduce the number of medications compared to standard care, indicating that while palliative care aims to improve quality of life, it may not impact the overall medication burden in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience. Granger, BB., Tulsky, JA., Kaufman, BG., et al.[2023]

Palliative care (PC) significantly improves outcomes for heart failure (HF) patients and their caregivers, enhancing aspects like dyspnea, sleep, and emotional wellbeing, while also reducing the need for medical services.

Despite its benefits, PC is underutilized among HF patients, especially in resource-limited countries, highlighting the need for early integration of PC into HF management and better training for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care in Heart Failure: A Public Health Emergency. Mosoiu, D., Rogozea, L., Landon, A., et al.[2021]

Out of 536 patients with advanced cancer, 45% were referred to palliative care (PC), with significant differences in access based on cancer type, particularly higher access for breast and gynecological cancers.

Patients referred to PC received less aggressive treatments, such as chemotherapy and intensive care, in their final weeks of life, indicating that PC may lead to a more comfortable end-of-life experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. Ledoux, M., Rhondali, W., Lafumas, V., et al.[2019]

Patients with heart failure (HF) are referred to palliative care (PC) later in their hospital stay compared to cancer patients, with an average delay of 4.6 days before consultation, which may limit the benefits of symptom management.

Despite being less likely to be referred for non-pain symptoms, patients with HF reported significant improvements in dyspnea after PC consultation, indicating that early involvement of PC could enhance symptom relief and overall care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Hospitalized Patients With Heart Failure and Cancer Referred to Palliative Care. Liu, AY., O'Riordan, DL., Marks, AK., et al.[2020]

The home-based palliative heart failure (HPHF) program significantly improved the quality of life (QOL) for patients with end-stage heart failure (ESHF), as evidenced by higher McGill QOL scores compared to the control group after 12 weeks.

Patients in the HPHF program reported greater satisfaction with their care and experienced lower caregiver burden, highlighting the program's effectiveness in supporting both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Home-Based Palliative Heart Failure Program on Quality of Life, Symptom Burden, Satisfaction and Caregiver Burden: A Randomized Controlled Trial. Ng, AYM., Wong, FKY.[2018]

The study involved interviews with 14 Iranian nurses to explore their experiences and perceptions of palliative care outcomes for cancer patients, revealing that palliative nursing is viewed as an abstract concept.

Two main themes emerged: 'providing excellent palliative care,' which emphasizes the importance of a humanistic approach and unique nursing qualities, and 'palliative care as an alarm,' highlighting the challenges and concerns nurses face in delivering care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Nursing for Cancer Patients as an Abstract Concept: A Hermeneutic Study. Borimnejad, L., Mardani-Hamooleh, M., Seyedfatemi, N., et al.[2018]

Palliative care (PC) significantly reduces hospital admissions for heart failure (HF) patients, with a notable odds ratio of 0.67, indicating its effectiveness in this group compared to other noncancer chronic illnesses where no significant reduction was observed.

Both HF and non-HF patients experienced increased advance care planning due to PC, with odds ratios of 4.29 and 2.67 respectively, highlighting the importance of PC in facilitating discussions about future care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Palliative Care Intervention With Health Care Use, Symptom Burden and Advance Care Planning in Adults With Heart Failure and Other Noncancer Chronic Illness. Maqsood, MH., Khan, MS., Warraich, HJ.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11956306/

Interventions to enable and reach patients with heart failure ... Challenges for Patients Dying of Heart Failure and Cancer. Circ ... Validity and Reliability of the Integrated Palliative Care Outcome Scale in ...

2. withpower.com withpower.com/trial/phase-intestinal-neoplasms-2024-1c435

Palliative Care for Heart Failure or Cancer (TIER-PC Trial) Research shows that palliative care can improve treatment outcomes for patients with heart failure and advanced cancer, enhancing their quality of life and ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06228209/tier-palliative-care-for-patients-with-advanced-heart-failure-or-cancer

Tier - Palliative Care for Patients with Advanced Heart ... Tier - Palliative Care for Patients with Advanced Heart Failure or Cancer. Last updated: February 25, 2025. Sponsor: Icahn School of Medicine at Mount Sinai.

4. bmjopen.bmj.com bmjopen.bmj.com/content/15/3/e100581.abstract

Interventions to enable and reach patients with heart failure ... ... heart failure and their caregivers, with palliative care ... 4. 1Division of Supportive and Palliative Care, National Cancer Centre Singapore, Singapore.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ehf2.15243

Elements of effective palliative care interventions in ... A comparison of hospitalized patients with heart failure and cancer referred to palliative care. JAMA Netw Open 2020; 3:e200020. doi:10.1001 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8459494/

Palliative care referral criteria and outcomes in cancer ... Cardiotoxicity resulting in heart failure (HF) is among the most dreaded complications of cancer therapy and can significantly impact morbidity ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03724695

Advanced Heart Care At Home (AHCAH) ... heart failure and palliative home care: Based on a randomized controlled trial. ... Early palliative care for patients with metastatic non-small-cell lung cancer.