Targeted palliative care program for people with metastatic breast cancer
Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
This trial will test a five-session TARGET-PC palliative care program to see if it helps people with metastatic breast cancer and their caregivers communicate better with clinicians and manage symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT06795529 on ClinicalTrials.gov |
What this trial studies
The study will randomize 400 patients with metastatic breast cancer and their identified caregivers across three cancer centers to either a five-session personalized palliative care program (TARGET-PC) or enhanced usual care that includes an electronic prompt for clinicians to discuss and record goals and preferences. TARGET-PC sessions are delivered by palliative care specialists working alongside oncology teams and focus on symptom management, communication about values and preferences, and coping skills. Primary outcomes include measures of communication quality, symptom burden, coping, understanding of care, and caregiver distress, with follow-up assessments to compare groups. The trial aims to determine whether a timely, personalized, and scalable palliative approach can be integrated into routine oncology care for people with long metastatic disease trajectories.
Who should consider this trial
Good fit: Adults (≥18) with metastatic breast cancer who receive care at one of the participating centers, have ECOG performance status ≤2, meet the Epic EOL Care Index eligibility within the prior 8 weeks, and can complete questionnaires in English or Spanish are ideal candidates.
Not a fit: Patients who have had an outpatient palliative care visit in the last six months, are enrolled in hospice, have cognitive or medical impairments that prevent informed consent, do not speak English or Spanish, or do not receive care at a participating site are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve symptom control, strengthen communication about care preferences, reduce caregiver distress, and improve quality of life for people with metastatic breast cancer.
How similar studies have performed: Previous trials of early palliative care in oncology have shown improved symptom relief, communication, mood, and quality of life, and TARGET-PC applies a targeted, multi-session model specifically for metastatic breast cancer across multiple centers.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion Criteria: * age ≥18 years * 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 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
Where this trial is running
Boston, Massachusetts and 2 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer Temel, MD
- Email: jtemel@mgh.harvard.edu
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.