Palliative And Oncology Care Model In Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Behavioral: Palliative and Oncology CareBehavioral: Standard Oncology Care
- Registration Number
- NCT02730858
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The purpose of this research study is to test a new way to deliver oncology and palliative care for patients with metastatic breast cancer.
* The goal of this study is to test a model where oncology and palliative care work together to care for participants with metastatic breast cancer who were recently admitted to the hospital or have new or worsening cancer involving their brain or the fluid around the brain or spinal cord.
* The investigators are studying whether participants who receive care from both teams have better communication about their care and improved quality of life and mood compared to those receiving care from only their oncologists.
The purpose of this randomized clinical trial is to conduct a randomized trial testing the impact of the collaborative palliative and oncology care model or standard oncology care models among patients with poor prognosis metastatic breast cancer. Participants assigned to the intervention arm will participate in a series of structured palliative care visits, following tailored clinical practice guidelines previously developed for patients with metastatic breast cancer.
- Detailed Description
This research study tests whether or not the earlier introduction of a team of clinicians that specialize in the lessening (palliation) of symptoms and addressing quality of life concerns may improve the end-of-life care, quality of life, and mood of women with poor prognosis metastatic breast cancer.
Palliative care is a specific type of medical care given to patients to improve their pain and other symptoms like fatigue, and to support patients and their families as they cope with their illness. Palliative care includes physicians and advanced practice nurses who have been specifically trained in how to help patients with serious illness.
Increasingly, the role of palliative care has been shown to benefit patients when introduced early in the disease trajectory. For example, in patients with metastatic (or spread) lung cancer, early involvement of palliative care improves patients' quality of life and mood. Patients with some metastatic cancers, like breast cancer, have an unpredictable disease trajectory, which makes it difficult to determine the best time to introduce palliative care services.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
- Already receiving palliative care in the outpatient setting.
- Active, untreated, unstable, serious mental illness (e.g., active, untreated psychotic, bi-polar, or substance-dependence disorder) interfering with ability to participate.
- Cognitive impairment (e.g., delirium, dementia) interfering with ability to participate.
- Requires urgent palliative or hospice care.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Palliative and oncology care model Palliative and Oncology Care After the screening procedure confirm eligibility to participate in the research study. Participants will be randomized into one of two study groups; -- Standard oncology care with palliative care. Standard oncology care Standard Oncology Care After the screening procedure confirm eligibility to participate in the research study. Participants will be randomized into one of two study groups; -- Standard oncology care
- Primary Outcome Measures
Name Time Method End of life care preference documentation 1 year Compare differences in rate of documentation of end of life care preferences (Yes documented vs. No)
- Secondary Outcome Measures
Name Time Method Patient-reported end of life care conversation 6 months Examine patient report of end of life care preferences with their clinician using the following item: "have you and your doctors discussed any particular wishes you have about the care you want to receive if you were dying?" Although patients complete this measure repeatedly during the course of the study, the investigators will use the final assessment either prior to death or at six months follow-up (whichever comes first) for this analysis.
Patient-reported quality of life (FACT-Breast) Weeks 6, 12, 18, and 24 Compare patient-reported quality of life between the two study arms at weeks 6, 12, 18, and 24.
Patient-reported depression symptoms (Hospital Anxiety and Depression Scale) Weeks 6, 12, 18, and 24 Compare patient-reported depression symptoms between the two study arms at weeks 6, 12, 18, and 24.
Patient-reported anxiety symptoms (Hospital Anxiety and Depression Scale) Weeks 6, 12, 18, and 24 Compare patient-reported anxiety symptoms between the two study arms at weeks 6, 12, 18, and 24.
Chemotherapy at the end of life 14, 7 and 3 days before death Examine differences in rates of chemotherapy administration during the last 3, 7, and 14 days of life between the two study arms
Rate of hospice utilization at the end of life 6 months Examine difference the in rates of hospice utilization between the two study arms.
Length of stay on hospice 6 months Examine difference in hospice length-of-stay between the two study arms.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States