Recruiting

Palliative Care Intervention

Sponsor:

Massachusetts General Hospital

Code:

NCT06795529

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Palliative Care Intervention, "TARGET-PC"

Enhanced Usual Care

Study Details

Brief summary:

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.

Conditions

Metastatic Breast Cancer

Study ID

NCT06795529

Start date

Oct 1, 2025

Status verified date

Nov, 2025

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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 and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02465

Contacts

Principal Investigator:

Jennifer Temel, MD

Duke University

Recruiting

Durham, North Carolina, United States, 54677

Contacts

Principal Investigator:

Thomas Leblanc, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 46205

Contacts

Principal Investigator:

Pallavi Kumar, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • palliative care
  • communication about care preferences

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-18.