Clinical trial NCT06795529: Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
Official title: Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: palliative care
communication about care preferences
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Duke University
name: University of Pennsylvania
First posted: 2025-01-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Patient 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

Primary outcomes:
measure: Documentation of End-of-Life Care Preferences
timeFrame: From date of randomization until date of death or last follow up assessed up to 60 months
Secondary outcomes:
measure: Hospice Utilization
timeFrame: From date of randomization until date of death or last follow up assessed up to 60 months
measure: Hospice Length of Stay
timeFrame: From date of randomization until date of death or last follow up assessed up to 60 months
measure: Death in the Hospital
timeFrame: From date of randomization until date of death or last follow up assessed up to 60 months
measure: Patient-reported Communication about End-of-Life Care Preferences
timeFrame: From date of randomization until date of death or last follow up assessed up to 60 months
Other outcomes:
measure: Patient Quality of Life (Functional Assessment of Cancer Therapy-Breast Scale)
timeFrame: 24 Weeks
measure: Patient Psychological Distress (Hospital Anxiety and Depression Scale - HADS)
timeFrame: 24 weeks
measure: Patient Coping (Brief COPE)
timeFrame: 24 weeks
measure: Caregiver Quality of Life (Caregiver Oncology QOL Questionnaire)
timeFrame: 24 Weeks
measure: Caregiver Psychological Distress (Hospital Anxiety and Depression Scale - HADS)
timeFrame: 24 weeks
measure: Caregiver Coping (Brief COPE)
timeFrame: 24 weeks
measure: Caregiver-reported Communication about the Patient's End-of-Life Care Preferences
timeFrame: From date of randomization until date of death or last follow up assessed up to 60 months
measure: Caregiver After Death Assessment
timeFrame: From date of randomization until three months after the patient's death assessed up to 60 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Greer JA, Moy B, El-Jawahri A, Jackson VA, Kamdar M, Jacobsen J, Lindvall C, Shin JA, Rinaldi S, Carlson HA, Sousa A, Gallagher ER, Li Z, Moran S, Ruddy M, Anand MV, Carp JE, Temel JS. Randomized Trial of a Palliative Care Intervention to Improve End-of-Life Care Discussions in Patients With Metastatic Breast Cancer. J Natl Compr Canc Netw. 2022 Feb;20(2):136-143. doi: 10.6004/jnccn.2021.7040.