Palliative and Oncology Care Model in Breast Cancer

NCT ID: NCT02730858

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2023-03-31

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Palliative and Oncology Care

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Standard Oncology Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Temel, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Temel, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35802350 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35130492 (View on PubMed)

Other Identifiers

15-585

Identifier Type: -

Identifier Source: org_study_id