Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06795529
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palliative Care Intervention, "TARGET-PC" — OTHER
    Palliative care intervention focused on eliciting patients' goals and values to facilitate discussion and documentation of health care preferences.
  • Enhanced Usual Care — OTHER
    Oncology clinicians will receive an electronic message to encourage them to discuss and document their patients' health care preferences.

Study Details

Many people living with metastatic breast cancer face challenging symptoms and frequent medical visits. At the same time, conversations about personal goals, values, and preferences for care may not always happen as early or as often as patients and families would like. This multi-site study will test the effectiveness of a five-session palliative care program, designed specifically for people with metastatic breast cancer and their caregivers, to strengthen communication with clinicians about what matters most in their care. The study aims to inform how palliative care services can be delivered in a more timely, personalized, and scalable way for people living with advanced cancers who have long disease trajectories, such as metastatic breast cancer.

Key Dates

Start date
Oct 1, 2025
Status verified
Nov 2025
Primary completion
Oct 1, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Documentation of End-of-Life Care Preferences [ Time Frame: From date of randomization until date of death or last follow up assessed up to 60 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02465
Jennifer Temel, MD
[email protected]
617-724-4000
Joseph Greer, PhD
[email protected]
617-724-4000
Jennifer Temel, MD (PRINCIPAL_INVESTIGATOR)
Joseph Greer, PhD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina54677
Thomas Leblanc, MD
[email protected]
919-684-8964
Thomas Leblanc, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania46205
Pallavi Kumar, MD, MPH
[email protected]
267-386-5553
Pallavi Kumar, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Massachusetts General Hospital· Boston, MADuke University· Durham, NCUniversity of Pennsylvania· Philadelphia, PA

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