Clinical trial · Interventional
Palliative and Oncology Care Model in Breast Cancer
A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative and Oncology Care | Behavioral | — | UNRESOLVED |
| Standard Oncology Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Palliative and oncology care model
- 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.
- interventionNames
- Behavioral: Palliative and Oncology Care
- type
- ACTIVE_COMPARATOR
- label
- Standard oncology care
- 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
- interventionNames
- Behavioral: Standard Oncology Care
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDRyan 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 35802350
- DERIVEDGreer 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 35130492