NCT02730858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.3 years

First QC Date

March 24, 2016

Last Update Submit

September 12, 2024

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast CancerPalliative CareBreast CancerEnd of lifeHealth service research

Outcome Measures

Primary Outcomes (1)

  • End of life care preference documentation

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

    1 year

Secondary Outcomes (7)

  • Patient-reported end of life care conversation

    6 months

  • Patient-reported quality of life (FACT-Breast)

    Weeks 6, 12, 18, and 24

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

    Weeks 6, 12, 18, and 24

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

    Weeks 6, 12, 18, and 24

  • Chemotherapy at the end of life

    14, 7 and 3 days before death

  • +2 more secondary outcomes

Study Arms (2)

Palliative and oncology care model

EXPERIMENTAL

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

Standard oncology care

ACTIVE COMPARATOR

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

Interventions

Palliative and Oncology CareBEHAVIORAL

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.

Palliative and oncology care model
Standard Oncology CareBEHAVIORAL

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.

Standard oncology care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    PMID: 35802350DERIVED

  • 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.

    PMID: 35130492DERIVED

MeSH Terms

Conditions

Breast NeoplasmsDeath

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jennifer Temel, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 7, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2019

Study Completion

March 1, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)