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

Trial Summary

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 data supports the effectiveness of the treatment TARGET-PC for breast cancer?

Research shows that palliative care can improve the quality of life for patients with advanced cancer, including those with breast cancer. Studies indicate that early and integrated palliative care helps with end-of-life discussions and enhances patient-reported outcomes. ^{1 2 3 4 5}

Is palliative care safe for breast cancer patients?

The research does not provide specific safety data for palliative care in breast cancer patients, but palliative care is generally aimed at improving quality of life and is widely used in cancer treatment. ^{3 4 5 6 7}

How is the TARGET-PC treatment different from other treatments for breast cancer?

TARGET-PC is unique because it focuses on integrating palliative care early in the treatment of breast cancer to improve quality of life and manage symptoms, unlike traditional treatments that may not prioritize palliative care until later stages. ^{3 6 8 9 10}

What is the purpose of this trial?

Patients with metastatic breast cancer who are approaching the end of life often experience high symptom burden and acute hospitalizations without sufficient communication with care teams about their end-of-life care wishes or the support of palliative or hospice services. 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 prognosis metastatic breast cancer and their caregivers to improve communication with clinicians and the quality of end-of-life care. This study will lay the groundwork for ultimately delivering scalable, timely, and tailored palliative care interventions for patients with advanced cancer who have long disease trajectories.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of a Palliative Care Intervention to Improve End-of-Life Care Discussions in Patients With Metastatic Breast Cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Introduction: Role of palliative care for the surgical patient. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Palliative care in the treatment of women with breast cancer: A scoping review. [2023]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Palliative Nursing for Cancer Patients as an Abstract Concept: A Hermeneutic Study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence, trend and disparities of palliative care utilization among hospitalized metastatic breast cancer patients who received critical care therapies. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Perspectives on Palliative Care in Cancer Clinical Trials: Diverse Meanings from Multidisciplinary Cancer Care Providers. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Retrospective analysis of the prevalence of specialised palliative care services for patients with metastatic breast cancer. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating Palliative Medicine into Comprehensive Breast Cancer Therapy - a Pilot Project. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Barriers to the integration of palliative care in Ghana: evidence from a tertiary health facility. [2023]