Clinical trial NCT02730858: Palliative and Oncology Care Model in Breast Cancer
Official title: A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer
Palliative Care
Breast Cancer
End of life
Health service research
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2016-04-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: End of life care preference documentation
timeFrame: 1 year
Secondary outcomes:
measure: Patient-reported end of life care conversation
timeFrame: 6 months
measure: Patient-reported quality of life (FACT-Breast)
timeFrame: Weeks 6, 12, 18, and 24
measure: Patient-reported depression symptoms (Hospital Anxiety and Depression Scale)
timeFrame: Weeks 6, 12, 18, and 24
measure: Patient-reported anxiety symptoms (Hospital Anxiety and Depression Scale)
timeFrame: Weeks 6, 12, 18, and 24
measure: Chemotherapy at the end of life
timeFrame: 14, 7 and 3 days before death
measure: Rate of hospice utilization at the end of life
timeFrame: 6 months
measure: Length of stay on hospice
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer Temel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.