Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
NCT ID: NCT06795529
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2025-10-01
2030-03-31
Brief Summary
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Detailed Description
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Research has shown that when palliative care and oncology teams collaborate closely, patients often experience better symptom relief, clearer communication about their goals and preferences, improved quality of life and mood, and a stronger understanding of their illness. Caregivers also report feeling more supported and less distressed.
The purpose of this research study is to learn whether a personalized palliative care program for people with metastatic breast cancer and their caregivers, called TARGET-PC, can further improve communication, symptom management, coping skills, and understanding of care.
In this study, 400 patients with metastatic breast cancer and their caregivers will be randomly assigned to receive either the TARGET-PC program or enhanced usual care. Enhanced usual care includes an electronic prompt that reminds oncology clinicians to discuss and record each patient's goals and preferences for care. The study will take place at the Massachusetts General Hospital Cancer Center, Penn Abramson Cancer Center, and Duke Cancer Center.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Palliative Care Intervention, "TARGET-PC"
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.
Palliative Care Intervention, "TARGET-PC"
Palliative care intervention focused on eliciting patients' goals and values to facilitate discussion and documentation of health care preferences.
Enhanced Usual Care
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.
Enhanced Usual Care
Oncology clinicians will receive an electronic message to encourage them to discuss and document their patients' health care preferences.
Interventions
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Palliative Care Intervention, "TARGET-PC"
Palliative care intervention focused on eliciting patients' goals and values to facilitate discussion and documentation of health care preferences.
Enhanced Usual Care
Oncology clinicians will receive an electronic message to encourage them to discuss and document their patients' health care preferences.
Eligibility Criteria
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Inclusion Criteria
* diagnosed with metastatic breast cancer
* within 8 weeks of the oncology visit at which they were identified as having an eligible Epic EOL Care Index (≥ 15)
* 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
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Duke University
OTHER
University of Pennsylvania
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Jennifer Temel, MD
Co-Principal Investigator
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Jennifer Temel, MD
Role: primary
Joseph Greer, PhD
Role: backup
Thomas Leblanc, MD
Role: primary
Pallavi Kumar, MD, MPH
Role: primary
References
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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.
Other Identifiers
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24-723
Identifier Type: -
Identifier Source: org_study_id