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Palliative And Oncology Care Model In Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative and Oncology Care
Standard Oncology Care
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Breast Cancer focused on measuring Metastatic Breast Cancer, Palliative Care, Breast Cancer, End of life, Health service research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Palliative and oncology care model

Standard oncology care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient-reported end of life care conversation
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)
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)
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)
Compare patient-reported anxiety symptoms between the two study arms at weeks 6, 12, 18, and 24.
Chemotherapy at the end of life
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
Examine difference the in rates of hospice utilization between the two study arms.
Length of stay on hospice
Examine difference in hospice length-of-stay between the two study arms.

Full Information

First Posted
March 24, 2016
Last Updated
March 18, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Comprehensive Cancer Network
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1. Study Identification

Unique Protocol Identification Number
NCT02730858
Brief Title
Palliative And Oncology Care Model In Breast Cancer
Official Title
A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
March 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Comprehensive Cancer Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Metastatic Breast Cancer, Palliative Care, Breast Cancer, End of life, Health service research

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palliative and oncology care model
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard oncology care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Palliative and Oncology Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Oncology Care
Intervention Description
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 Outcome Measure Information:
Title
End of life care preference documentation
Description
Compare differences in rate of documentation of end of life care preferences (Yes documented vs. No)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient-reported end of life care conversation
Description
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.
Time Frame
6 months
Title
Patient-reported quality of life (FACT-Breast)
Description
Compare patient-reported quality of life between the two study arms at weeks 6, 12, 18, and 24.
Time Frame
Weeks 6, 12, 18, and 24
Title
Patient-reported depression symptoms (Hospital Anxiety and Depression Scale)
Description
Compare patient-reported depression symptoms between the two study arms at weeks 6, 12, 18, and 24.
Time Frame
Weeks 6, 12, 18, and 24
Title
Patient-reported anxiety symptoms (Hospital Anxiety and Depression Scale)
Description
Compare patient-reported anxiety symptoms between the two study arms at weeks 6, 12, 18, and 24.
Time Frame
Weeks 6, 12, 18, and 24
Title
Chemotherapy at the end of life
Description
Examine differences in rates of chemotherapy administration during the last 3, 7, and 14 days of life between the two study arms
Time Frame
14, 7 and 3 days before death
Title
Rate of hospice utilization at the end of life
Description
Examine difference the in rates of hospice utilization between the two study arms.
Time Frame
6 months
Title
Length of stay on hospice
Description
Examine difference in hospice length-of-stay between the two study arms.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Temel, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35802350
Citation
Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
Results Reference
derived
PubMed Identifier
35130492
Citation
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.
Results Reference
derived

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Palliative And Oncology Care Model In Breast Cancer

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