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NCT Number: NCT02730858

Palliative and Oncology Care Model in Breast Cancer

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Death Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with metastatic breast cancer and:
  • have been informed of a diagnosis of leptomeningeal disease in the past eight weeks; OR
  • have been informed of a diagnosis of progressive brain metastases after initial radiation therapy in the past eight weeks; OR
  • have been diagnosed brain metastases and began whole brain radiation in the past eight weeks; OR
  • had an unplanned hospital admission and was discharged within the past eight weeks; OR
  • have been diagnosed with triple negative breast cancer and started second-line treatment in the past eight weeks; OR
  • have started the third regimen in one year within the past eight weeks; OR
  • have HER2+ disease and started third-line therapy within the past eight weeks; OR
  • have ER+ disease and started third-line chemotherapy within the past eight weeks; OR
  • enrolled on a clinical trial within the past eight weeks
  • Receiving cancer care at MGH Cancer Center.
  • Able to read and write in English.
  • Eastern Cooperative Oncology Group status between 0 and 2.

Exclusion criteria

  • 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.

Treatment and study plan

Palliative and Oncology Care

Behavioral

Patients randomized to the intervention will receive collaborative care from palliative care and oncology for the remainder of their illness. The initial five visits with palliative care will be conducted in accordance with the study specific clinical practice guidelines and occur at least monthly.

Standard Oncology Care

Behavioral

Patients randomized to oncology care alone will continue to receive routine care identical to what they would have received if they had not participated in the trial. Either patients or their oncologists can request palliative care consultation at any point in time.

Primary outcomes

  1. End of life care preference documentation

    Time frame: 1 year

    Compare differences in rate of documentation of end of life care preferences (Yes documented vs. No)

Secondary outcomes

  1. Patient-reported end of life care conversation

    Time frame: 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.

  2. Patient-reported quality of life (FACT-Breast)

    Time frame: Weeks 6, 12, 18, and 24

    Compare patient-reported quality of life between the two study arms at weeks 6, 12, 18, and 24.

  3. Patient-reported depression symptoms (Hospital Anxiety and Depression Scale)

    Time frame: Weeks 6, 12, 18, and 24

    Compare patient-reported depression symptoms between the two study arms at weeks 6, 12, 18, and 24.

  4. Patient-reported anxiety symptoms (Hospital Anxiety and Depression Scale)

    Time frame: Weeks 6, 12, 18, and 24

    Compare patient-reported anxiety symptoms between the two study arms at weeks 6, 12, 18, and 24.

  5. Chemotherapy at the end of life

    Time frame: 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

  6. Rate of hospice utilization at the end of life

    Time frame: 6 months

    Examine difference the in rates of hospice utilization between the two study arms.

  7. Length of stay on hospice

    Time frame: 6 months

    Examine difference in hospice length-of-stay between the two study arms.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Official study title

A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer

Important dates

Study start
2016
Primary completion
2019
Study completion
2023
First posted
Apr 7, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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