Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer

NCT06795529 | Recruiting DMC

• 2 other identifiers: 24-723R01CA299956
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

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

Keywords

palliative care; communication about care preferences

Outcome Measures

Primary Outcomes (1)

• Documentation of End-of-Life Care Preferences

  To compare proportions of patients with clinician-documented end-of-life care preferences in the electronic health record by last follow-up time point or date of death between study groups.

  From date of randomization until date of death or last follow up assessed up to 60 months

Secondary Outcomes (4)

• Hospice Utilization

  From date of randomization until date of death or last follow up assessed up to 60 months

• Hospice Length of Stay

  From date of randomization until date of death or last follow up assessed up to 60 months

• Death in the Hospital

  From date of randomization until date of death or last follow up assessed up to 60 months

• Patient-reported Communication about End-of-Life Care Preferences

  From date of randomization until date of death or last follow up assessed up to 60 months

Other Outcomes (8)

• Patient Quality of Life (Functional Assessment of Cancer Therapy-Breast Scale)

  24 Weeks

• Patient Psychological Distress (Hospital Anxiety and Depression Scale - HADS)

  24 weeks

• Patient Coping (Brief COPE)

  24 weeks

Study Arms (2)

Palliative Care Intervention, "TARGET-PC"

EXPERIMENTAL

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.

Other: Palliative Care Intervention, "TARGET-PC"

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Other: Enhanced Usual Care

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.

Palliative Care Intervention, "TARGET-PC"

Enhanced Usual Care OTHER

Oncology clinicians will receive an electronic message to encourage them to discuss and document their patients' health care preferences.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator
• Duke University: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02465, United States

RECRUITING

Duke University

Durham, North Carolina, 54677, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 46205, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35130492 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jennifer Temel, MD

CONTACT

617-724-4000; jtemel@mgh.harvard.edu

Joseph Greer, PhD

CONTACT

617-724-4000; jgreer2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 28, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be submitted to a publicly available database within three months of study completion and maintained in perpetuity.
• Access Criteria: Most of the scientific data generated in this study, including the self-report and electronic health record data, will be made publicly available through the Harvard Dataverse. However, certain sociodemographic information and any other variables that are considered Protected Health Information and potentially identifying the patient participants (e.g., dates of birth and death) will be restricted. Restricted data would only be made available to users who demonstrate a valid research need and meet conditions of use. In accordance with the data repository methods, we will require the completion of a data use agreement form that stipulates data sharing under IRB-approved protocols.

Locations

US (3)