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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative and Oncology Care | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| End of life care preference documentation | Compare differences in rate of documentation of end of life care preferences (Yes documented vs. No) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Diagnosed with metastatic breast cancer and:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Temel, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35802350 | Derived | 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. | |
| 35130492 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003643 | Death |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Standard Oncology Care | 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. |
|
| 6 months |
| 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. | 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. | 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. | 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 | 14, 7 and 3 days before death |
| Rate of hospice utilization at the end of life | Examine difference the in rates of hospice utilization between the two study arms. | 6 months |
| Length of stay on hospice | Examine difference in hospice length-of-stay between the two study arms. | 6 months |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |