Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT06795529
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

The goal of this proposal is to improve care delivery for patients with metastatic breast cancer (MBC) and the experience of their family members ("caregivers"). Clinical guidelines recommend an approach to end-of-life (EOL) care that focuses less on aggressive treatment and more on palliating symptoms and clarifying patients' goals and wishes. However, compared to other advanced cancer populations, patients with MBC are at increased risk of receiving chemotherapy in the final weeks before death and subsequently dying in the hospital, lacking the support of palliative and hospice services. With effective patient-clinician communication about prognosis and EOL care preferences, most patients choose to defer futile cancer therapy and receive hospice services prior to their death. Caregivers also experience improved psychological outcomes when patients receive hospice services and die at home. Thus, interventions to improve EOL care communication and delivery offer a promising approach to enhance outcomes for both patients with MBC and their caregivers. Studies show that early integration of palliative and oncology care for patients with serious cancers improves not only quality of life (QOL) but also patient-clinician communication about EOL care preferences and delivery. This evidence-based care model entails frequent contact with a palliative care clinician in the outpatient setting from the time of diagnosis of a poor prognosis cancer until death. However, such longitudinal visits are not feasible for patients with long illness trajectories, such as MBC, who have benefited from treatment advances extending survival. While briefer palliative care interventions enhance patient-reported outcomes, they have failed to improve EOL care communication or delivery. Also, interventions targeting oncology clinicians' communication with patients have not improved EOL care outcomes. A novel approach to involving palliative care to improve communication and delivery of EOL care for patients with a long cancer trajectory, such as MBC, is needed. To address this evidence gap, the investigators developed a five-session targeted palliative care intervention specifically for patients with MBC (called TARGET-PC), which focuses on coping with advanced cancer, illness understanding, treatment decision-making, and EOL care planning. The investigators completed a single-site randomized trial of the TARGET-PC versus usual care among 120 patients with MBC identified as having a poor prognosis. Compared to usual care, patients assigned to TARGET-PC were more likely to report discussing their EOL care preferences (OR=3.10, p=0.019) and to have a documented EOL discussion (OR=2.92, p=0.005) in the electronic health record (EHR). Intervention participants were also more likely to receive hospice services (OR=4.03, p=0.035) versus the usual care group. While these EOL care outcomes were clinically meaningful, identifying those with poor-prognosis MBC remains a challenge, as \>50% of the sample was alive at one year follow-up. The investigators now propose to conduct a multi-site efficacy trial of TARGET-PC versus an enhanced usual care control condition consisting of an electronic prompt encouraging oncology clinicians to discuss and document patients' EOL care preferences. In our pilot trial, the investigators used a manual chart review of clinical characteristics to identify patients with a prognosis of 6-12 months. However, recent studies have demonstrated that machine learning prognostic models, such as the Epic End-of-Life Care Index, offer innovative, valid, and scalable means to identify patients at risk of death who may benefit from palliative care interventions. The investigators have assembled a team of experts in machine learning prognostic models and their clinical and ethical application in oncology care to enable us to identify the proposed study cohort of 400 patients with MBC at risk of death within one year. The Massachusetts General Hospital Cancer Center, Penn Abramson Cancer Center, and Duke Cancer Center will serve as study sites. If proven efficacious, TARGET-PC and the machine learning screening methods could be adapted for subpopulations of patients with advanced cancer with increasingly longer survival trajectories, significantly advancing the field.

Study Timeline

• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2025-10-01
• Primary Completion: 2029-10-01
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• age ≥18 years
• diagnosed with metastatic breast cancer
• identified as at risk of death within 12 months per the Epic End-of-Life Care Index
• functioning independently per an Eastern Cooperative Oncology Group performance status ≤2
• receiving their cancer care at one of the participating institutions
• able to complete questionnaires in English or Spanish

Patient

Exclusion Criteria

• received outpatient palliative care visit within the last six months
• enrolled in hospice services
• 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)

Caregiver Inclusion Criteria:

• age ≥18 years
• identified by the patient as a family member or friend who is primarily involved in their care
• able to complete questionnaires in English or Spanish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Documentation of End-of-Life Care Preferences	From date of randomization until date of death or last follow up assessed up to 60 months	To compare proportions of patients with clinician-documented end-of-life care preferences in the electronic health record by last follow-up time point or date of death between study groups.

Secondary Outcome Measures

Name	Time	Method
Death in the Hospital	From date of randomization until date of death or last follow up assessed up to 60 months	To compare proportions of patients dying in the hospital between study groups among patients who die during study follow up.
Hospice Utilization	From date of randomization until date of death or last follow up assessed up to 60 months	To compare proportions of patients using hospice services by last follow up time point or death of death between study groups.
Patient-reported Communication about End-of-Life Care Preferences	From date of randomization until date of death or last follow up assessed up to 60 months	To compare proportions with patient-reported communication about their end-of-life care preferences between study groups by last follow-up time point or date of death using the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ has a single item in which patients indicate whether they have discussed their end-of-life care wishes with their clinicians (scored dichotomously as "yes or no").
Hospice Length of Stay	From date of randomization until date of death or last follow up assessed up to 60 months	To compare patients' lengths of stay in hospice between study groups among patients who die during study follow up.

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States