UPCC 17125 Randomized Trial of a Targeted Palliative Care Intervention for Patients with Metastatic Breast Cancer (TARGET-PC) (TARGET-PC)
Study of Palliative Care Program for Patients with Metastatic Breast Cancer
Brief description of study
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 of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Metastatic Breast Cancer
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Age: 18 years or above
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Gender: All
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
This study investigates a targeted palliative care program for individuals with metastatic breast cancer and their caregivers. The aim of this study is to enhance communication between patients, caregivers, and clinicians about the patients' goals and preferences for care.
Participants in the study will be randomly assigned to receive either the TARGET-PC palliative care program or enhanced usual care. The TARGET-PC program consists of five sessions designed to improve symptom management, communication, and coping skills. Enhanced usual care includes electronic reminders for oncology clinicians to discuss care preferences with patients. This study will involve 400 patients and will take place at three cancer centers.
- Who can participate: Adults aged 18 or older with metastatic breast cancer who have been identified within 8 weeks of an eligible oncology visit and are functioning independently can participate. They must receive cancer care at one of the participating institutions and be able to complete questionnaires in English or Spanish. Caregivers must be 18 or older, identified by the patient as a primary caregiver, and able to complete questionnaires in English or Spanish.
- Study details: Participants must be able to complete questionnaires in English or Spanish.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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