Metastatic Breast CancerTARGET-PCNCT06795529
Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
A study testing Palliative Care Intervention, "TARGET-PC" in people with Metastatic Breast Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Palliative Care Intervention, "TARGET-PC"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2025to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02465
Jennifer Temel, MD, 617-724-4000, jtemel@mgh.harvard.edu
Joseph Greer, PhD, 617-724-4000, jgreer2@mgh.harvard.edu
- Recruiting
Duke University
Durham, North Carolina, 54677
Thomas Leblanc, MD, 919-684-8964, thomas.leblanc@duke.edu
Thomas Leblanc, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 46205
Pallavi Kumar, MD, MPH, 267-386-5553, pallavi.kumar@pennmedicine.upenn.edu
Pallavi Kumar, MD, MPH
About this study
Official title: Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
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.
Read the detailed description
The diagnosis of metastatic breast cancer can bring many challenges including physical symptoms, treatment side effects, and emotional stress for patients and their families. Palliative care specialists work alongside the oncology team to help patients and families manage symptoms, communicate effectively with their clinicians, and cope with the impact of living with cancer.
Research has shown that when palliative care and oncology teams collaborate closely, patients often experience better symptom relief, clearer communication about their goals and preferences, improved quality of life and mood, and a stronger understanding of their illness. Caregivers also report feeling more supported and less distressed.
The purpose of this research study is to learn whether a personalized palliative care program for people with metastatic breast cancer and their caregivers, called TARGET-PC, can further improve communication, symptom management, coping skills, and understanding of care.
In this study, 400 patients with metastatic breast cancer and their caregivers will be randomly assigned to receive either the TARGET-PC program or enhanced usual care. Enhanced usual care includes an electronic prompt that reminds oncology clinicians to discuss and record each patient's goals and preferences for care. The study will take place at the Massachusetts General Hospital Cancer Center, Penn Abramson Cancer Center, and Duke Cancer Center.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Palliative Care Intervention, "TARGET-PC", Enhanced Usual Care
- Keywords
- palliative care, communication about care preferences
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 CareOther
Oncology clinicians will receive an electronic message to encourage them to discuss and document their patients' health care preferences.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until date of death or last follow up assessed up to 60 months
Secondary outcomes (4)
Hospice Utilization
To compare proportions of patients using hospice services by last follow up time point or death of death between study groups.
Measured: From date of randomization until date of death or last follow up assessed up to 60 months
Hospice Length of Stay
To compare patients' lengths of stay in hospice between study groups among patients who die during study follow up.
Measured: From date of randomization until date of death or last follow up assessed up to 60 months
Death in the Hospital
To compare proportions of patients dying in the hospital between study groups among patients who die during study follow up.
Measured: 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
To compare proportions with patient-reported communication about their end-of-life care preferences between study groups by last follow-up time point or date of death using the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ has a single item in which patients indicate whether they have discussed their end-of-life care wishes with their clinicians (scored dichotomously as "yes or no").
Measured: From date of randomization until date of death or last follow up assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Temel, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795529
- Sponsor's protocol ID
- 24-723
- Other IDs
- R01CA299956
- Acronym
- TARGET-PC
- Status last verified
- Nov 2025
- First submitted
- 18 Jan 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The total scale, subscale scores, and item-level scores from the self-report measures, sociodemographic information, electronic health record data, and palliative care visit surveys will be preserved and stored within a secure computing environment. All participant identifiers will be removed and maintained in a separate secure file that will not be shared to protect confidentiality.
Publications
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.
PubMed 35130492
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06795529
- Acronym / sponsor ID
- TARGET-PC / 24-723
- Conditions
- Metastatic Breast Cancer
- Keywords
- palliative care, communication about care preferences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Duke University, University of Pennsylvania
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The diagnosis of metastatic breast cancer can bring many challenges including physical symptoms, treatment side effects, and emotional stress for patients and their families. Palliative care specialists work alongside the oncology team to help patients and families manage symptoms, communicate effectively with their clinicians, and cope with the impact of living with cancer.
Research has shown that when palliative care and oncology teams collaborate closely, patients often experience better symptom relief, clearer communication about their goals and preferences, improved quality of life and mood, and a stronger understanding of their illness. Caregivers also report feeling more supported and less distressed.
The purpose of this research study is to learn whether a personalized palliative care program for people with metastatic breast cancer and their caregivers, called TARGET-PC, can further improve communication, symptom management, coping skills, and understanding of care.
In this study, 400 patients with metastatic breast cancer and their caregivers will be randomly assigned to receive either the TARGET-PC program or enhanced usual care. Enhanced usual care includes an electronic prompt that reminds oncology clinicians to discuss and record each patient's goals and preferences for care. The study will take place at the Massachusetts General Hospital Cancer Center, Penn Abramson Cancer Center, and Duke Cancer Center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palliative Care Intervention, "TARGET-PC" | Experimental | Other: 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. |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Care Intervention, "TARGET-PC"Palliative care intervention focused on eliciting patients' goals and values to facilitate discussion and documentation of health care preferences. | Other | Palliative Care Intervention, "TARGET-PC" |
| Enhanced Usual CareOncology clinicians will receive an electronic message to encourage them to discuss and document their patients' health care preferences. | Other | Enhanced Usual Care |
Primary outcome
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
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.
4 secondary outcomes
Hospice Utilization
Time frame: From date of randomization until date of death or last follow up assessed up to 60 months
Hospice Length of Stay
Time frame: From date of randomization until date of death or last follow up assessed up to 60 months
Death in the Hospital
Time frame: 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
Time frame: From date of randomization until date of death or last follow up assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 35130492Greer 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.
- Individual participant dataSharing planned: Yes. The total scale, subscale scores, and item-level scores from the self-report measures, sociodemographic information, electronic health record data, and palliative care visit surveys will be preserved and stored within a secure computing environment. All participant identifiers will be removed and maintained in a separate secure file that will not be shared to protect confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care Intervention, "TARGET-PC" in people with Metastatic Breast Cancer, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Temel, MD (617-724-4000, jtemel@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.