Palliative Care for Breast Cancer

(TARGET-PC Trial)

Recruiting at 2 trial locations

Overseen By Joseph Greer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Outpatient palliative, Hospice, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 5

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve end-of-life care for patients with advanced breast cancer by testing a special palliative care program called TARGET-PC. The program emphasizes better communication with doctors and ensures that patients' care preferences are understood and respected. Participants will receive either enhanced usual care with reminders for doctors or the new palliative care intervention. Those with metastatic breast cancer, likely to die within a year, and currently receiving cancer treatment at a participating location may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to advancements in palliative care, potentially enhancing the quality of life for future patients.

Do I need to stop my current medications to join the trial?

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 intervention is safe for patients with metastatic breast cancer?

Research shows that palliative care treatments, like TARGET-PC, are generally safe for people with serious illnesses, including those with advanced breast cancer. Although specific safety data for TARGET-PC is not yet available, palliative care is widely used and aims to improve quality of life. It manages symptoms and enhances communication with healthcare providers, rather than treating the cancer itself.

Previous studies have found that these treatments are well-tolerated by patients. They help manage symptoms like pain and stress without causing significant side effects. Patients often feel more supported and report better communication with their healthcare teams.

In summary, palliative care, such as TARGET-PC, is considered safe. It focuses on enhancing comfort and the quality of care for patients facing serious health challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TARGET-PC approach because it integrates palliative care directly into the oncology treatment plan for breast cancer patients. Unlike standard treatments that often focus solely on managing the cancer itself, TARGET-PC emphasizes holistic care by involving palliative care specialists right from the start. This approach aims to enhance the quality of life by addressing not just physical symptoms, but also emotional and psychological well-being. Additionally, the use of video and phone consultations makes this care more accessible and flexible, ensuring continuous support for patients even if they can't attend in-person visits. This comprehensive care model could lead to better patient outcomes and satisfaction.

What evidence suggests that this trial's treatments could be effective for improving end-of-life care in metastatic breast cancer?

Research has shown that the TARGET-PC program, available to participants in this trial, can greatly enhance communication about end-of-life care for patients with advanced breast cancer. Studies have found that this specialized care helps patients and their caregivers discuss and plan care preferences more effectively. Early results suggest that this approach improves the quality of care during the final stages of life. By focusing on personalized care sessions, it addresses the specific needs of patients with advanced cancer, making their care more compassionate and effective. Overall, this method aims to reduce hospital visits and improve the patient's quality of life. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic breast cancer who are nearing the end of life. It aims to help them and their caregivers by improving communication with healthcare teams and enhancing the quality of end-of-life care.

Inclusion Criteria

I can complete questionnaires in English or Spanish.

Patients must be identified as at risk of death within 12 months per the Epic End-of-Life Care Index

I have been diagnosed with breast cancer that has spread.

Exclusion Criteria

I visited a palliative care specialist as an outpatient in the last 6 months.

Patients enrolled in hospice services

Patients diagnosed with a comorbid condition that impairs their ability to understand study procedures and/or consent for the trial as per the report of the oncology clinician(s)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Palliative Care Intervention

Participants receive a five-session targeted palliative care intervention designed to improve communication with clinicians and the quality of end-of-life care.

5 months

5 visits (in-person or virtual)

Enhanced Usual Care

Oncology clinicians receive electronic health record prompts to discuss and document patients' end-of-life care preferences.

5 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments of hospice utilization and end-of-life care preferences.

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• TARGET-PC

Trial Overview

The study tests a five-session palliative care intervention called 'TARGET-PC' against enhanced usual care. The goal is to see if TARGET-PC can better support patients and caregivers in managing symptoms and making end-of-life decisions.

How Is the Trial Designed?

Group I: Palliative Care Intervention, "TARGET-PC" Experimental Treatment 1 Intervention

Patients randomly assigned to TARGET-PC will receive the palliative care intervention in addition to usual oncology care. Palliative care intervention visits will be conducted by a palliative care physician or advanced practice provider either in-person or with hospital-approved videoconference technology. Patients will be scheduled for their first palliative care visit within four weeks of randomization. Subsequent palliative care intervention visits will be scheduled every four weeks until the patient completes visit five. If a patient cannot be scheduled for intervention visits within four weeks, the palliative care clinician will contact them via telephone within four weeks of their prior contact to maintain their relationship and rapport. Palliative care clinicians will be permitted to conduct an intervention visit over the phone or video if they feel it is appropriate based on the patient's health status.

Group II: Enhanced Usual Care Active Control 1 Intervention

The oncology clinicians (physicians and advanced practice providers) of patients randomly assigned to the enhanced usual care condition will receive electronic prompts, encouraging them to discuss and document their patient's care preferences for up to five months after the patient is randomized. The prompts will be sent electronically. The research assistant will send the first electronic prompt on the morning of the outpatient oncology appointment immediately following the visit at which the patient provided informed consent for the study. Subsequent electronic prompts will be sent on the morning of outpatient oncology appointments for five months, but no more often than every four weeks.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06795529

Targeted Palliative Care Intervention for Patients With ...

The purpose of this multi-site trial is to test the efficacy of a targeted, five-session palliative care intervention designed specifically for those with poor ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/11103432

temel, jennifer sue - NIH RePORTER

TARGET-PC significantly improved EOL care communication and delivery in this population, though identifying the subgroup of patients with MBC at risk of death ...

3.

trialx.com

trialx.com/clinical-trials/listings/314239/targeted-palliative-care-intervention-for-patients-with-metastatic-breast-cancer/

Targeted Palliative Care Intervention for Patients With ...

The purpose of this multi-site trial is to test the efficacy of a targeted, five-session palliative care intervention designed specifically for ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8830600/

Randomized Trial of a Palliative Care Intervention to Improve ...

This study demonstrates the beneficial role of ambulatory PC when targeted to the needs of a specific population, such as those with MBC.

5.

academic.oup.com

academic.oup.com/oncolo/article/29/5/e708/7612818

Palliative Care Interventions and End-of-Life Care for Patients ...

The aim of this study was to describe the implementation of integrated palliative care (PC) and the intensity of care in the last 3 months before death for ...

6.

withpower.com

withpower.com/trial/palliative-care-for-breast-cancer-925f2

Palliative Care for Breast Cancer (TARGET-PC Trial)

Is palliative care safe for breast cancer patients? The research does not provide specific safety data for palliative care in breast cancer patients, but ...

7.

ascopubs.org

ascopubs.org/doi/10.1200/OP-24-00892

Early Integration of Outpatient Palliative Care Among ...

Outcomes assessed included (1) receipt of PC referral ≤8 weeks after diagnosis, (2) receipt of any PC referral, and (3) PC visit completion.