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Trial record 1 of 1 for:    NCT02730858
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Palliative And Oncology Care Model In Breast Cancer

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ClinicalTrials.gov Identifier: NCT02730858
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : March 21, 2023
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Jennifer Temel, MD, Massachusetts General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Behavioral: Palliative and Oncology Care Behavioral: Standard Oncology Care Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer
Study Start Date : May 2016
Actual Primary Completion Date : September 2019
Actual Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Palliative and oncology care model

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.

 Behavioral: Palliative and Oncology Care
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.
Active Comparator: 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

 Behavioral: Standard Oncology Care
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Diagnosed with metastatic breast cancer and:

    1. have been informed of a diagnosis of leptomeningeal disease in the past eight weeks; OR
    2. have been informed of a diagnosis of progressive brain metastases after initial radiation therapy in the past eight weeks; OR
    3. have been diagnosed brain metastases and began whole brain radiation in the past eight weeks; OR
    4. had an unplanned hospital admission and was discharged within the past eight weeks; OR
    5. have been diagnosed with triple negative breast cancer and started second-line treatment in the past eight weeks; OR
    6. have started the third regimen in one year within the past eight weeks; OR
    7. have HER2+ disease and started third-line therapy within the past eight weeks; OR
    8. have ER+ disease and started third-line chemotherapy within the past eight weeks; OR
    9. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730858


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
National Comprehensive Cancer Network
Investigators
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Principal Investigator: Jennifer Temel, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02730858    
Other Study ID Numbers: 15-585
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jennifer Temel, MD, Massachusetts General Hospital:
Metastatic Breast Cancer
Palliative Care
Breast Cancer
End of life
Health service research
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases