Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Contact Information
Primary
Jennifer Temel, MD
jtemel@mgh.harvard.edu
617-724-4000
Backup
Joseph Greer, PhD
jgreer2@mgh.harvard.edu
617-724-4000
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 400
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Duke University, National Cancer Institute (NCI), University of Pennsylvania

This content was sourced from clinicaltrials.gov